Improvement In Oral Intake Research Articles

Functional Laryngectomy and Quality of Life in Survivors of Head and Neck Cancer With Intractable Aspiration

Late effects of head and neck cancer (HNC) treatment include profound dysphagia, chronic aspiration, and death. Functional laryngectomy (FL) can improve patient survival and quality of life (QoL); however, removing a failing larynx for a noncancer reason is a difficult decision. Data regarding the ability of FL to improve self-perceptions of voice, swallowing, and QOL in survivors of HNC with intractable aspiration are inconclusive. To investigate the association of FL with changes in self-reported perceptions of voice, swallowing, oral intake, QoL, and mood in survivors of HNC experiencing profound dysphagia and intractable aspiration. This cohort study was conducted at a single academic institution and included survivors of HNC with profound swallowing dysfunction and intractable aspiration who underwent FL from July 2016 through March 2022. Of the initial 22 patients enrolled, 2 patients (15%) died of aspiration pneumonia before receiving FL. Data analyses were performed from July 2016 through March 2023. Self-reported measures of voice using the VHI (30-item Voice Handicap Index), swallowing using the EAT-10 (10-item Eating Assessment Tool), functional oral intake scale using the FOIS (Functional Oral Intake Scale), and quality of life using the FACT-H&N (Functional Assessment of Cancer Therapy-Head & Neck) were assessed before FL and at 1, 3, and 6 months after FL. Mood states were evaluated using the POMS (Profile of Mood States, second edition), before FL and at 6 months after FL. The study analyses included 20 patients (mean [SD] age, 72.4 (7.0) years; 19 [95%] males and 1 [5%] female) who underwent FL and had complete data across all time points. Among these, 12 patients (60%) had received chemoradiation for oropharyngeal, 7 (35%) for laryngeal, or 1 (5%) for nasopharyngeal cancer. The mean (SD) time from completion of oncologic treatment to FL was 15.5 (5.5) years. Mean (SD) score on the EAT-10 improved from 33.2 (7.4) to 23.1 (10.8) at 1 month; 12.1 (9.1) at 3 months; and 8.3 (7.4) at 6 months, with a large effect size (η2 = 0.72; 95% CI, 0.54-0.80). Mean (SD) score on the FOIS improved from 2.0 (1.5) to 2.9 (1.7) at 1 month; 4.8 (2.5) at 3 months; and 5.2 (1.7) at 6 months, with a large effect size (η2 = 0.6; 95% CI, 0.38-0.71). Improvement in oral intake was achieved in 19 patients (95%), and feeding tubes were removed in 10 of 16 patients (63%) who were feeding tube-dependent; 6 patients (27%) continued to require supplemental tube feedings. Mean (SD) score on the VHI improved from 63.6 (34.0) to 86.9 (33.7) at 1 month; 71.3 (36.1) at 3 months; and 39.7 (26.9) at 6 months, with a large effect size (η2 = 0.42; 95% CI, 0.19-0.56). Seventeen patients (85%) were able to use a tracheoesophageal voice prosthesis for alaryngeal communication. Mean (SD) score on the FACT-H&N improved from 86.2 (17.8) to 93.6 (18.4) at 1 month; 109.0 (18.4) at 3 months; and 121.0 (16.8) at 6 months, with a large effect size (η2 = 0.64; 95% CI, 0.42-0.74). Mean (SD) score on the POMS improved from 58.9 (13.2) at baseline to 44.5 (9.9) at 6 months, with a large effect size (Cohen d = 1.04; 95% CI, 0.48-1.57). None of the patients experienced major complications of FL; 1 patient (5%) had a postoperative pharyngocutaneous fistula. The findings of this cohort study indicate that FL was associated with marked improvements in self-perception of voice and swallowing, functional oral intake, QoL, and mood state among survivors of HNC. These findings can serve as a framework for FL counseling among HNC survivors experiencing profound dysphagia and intractable aspiration.

Abstract Number ‐ 234: Bilateral Non‐Painful Stimulus‐Induced Decerebrated Posturing In A Bilateral Pontine Ischemic Stroke: A Case Report

Introduction A 38 year‐old right‐handed female is a fully functional teacher with past medical history of hypertension, type II Diabetes Mellitus, polycystic ovarian syndrome, and infertility. She presented to our emergency department (ER) on the same day she was discharged twice from a local ER for acute onset persistent non‐fluctuating left‐sided weakness and painful bilateral leg spasms that woke her from sleep. Patient had pertinent exam findings of moderate pharyngeal dysarthria, mild right nasolabial flattening, mild weakness of left upper extremity (LUE), and stereotyped, painful tonic extensor posturing of the bilateral lower extremities associated with back arching and extensor response of bilateral toes. NIH Stroke Scale was 10. Methods We conducted a review of patient clinical documentation. Results MRI Brain showed anterior asymmetric bilateral pontine ischemic strokes at the ventral pontomedullary junction. MRA brain with black blood sequencing revealed multifocal vasculopathy at the right V4, mid‐basilar and left M1 segments. An angiogram showed Moya‐moya type collaterals. Tonic posturing and spasms persisted for several hours requiring muscle relaxants and benzodiazepines for symptomatic management. Unfortunately, the patient had worsening LUE weakness, inability to swallow and was found to have total vocal cord paralysis. She was intubated for airway protection and after failing extubation required tracheostomy and percutaneous gastrostomy placement. Initial workup revealed poorly controlled hyperlipidemia (LDL 162) and diabetes (A1c 8.7%), CRP 7–9, hypercoagulable panel and transthoracic echocardiogram were unremarkable. Lumbar puncture was also unremarkable (CSF TNC 2, RBC 3, glucose 116, protein 35, Enterovirus and HSV 1,2 PCR, Streptococcus antigen and VDRL were negative). Anticoagulation was started for an incidental right lower lobe subsegmental pulmonary embolism. Ultimately, the patient was discharged to inpatient rehabilitation (IPR) with a Modified Rankin Scale (mRS) of 4, on day 19th of hospitalization with some improvement in oral intake and decannulation of tracheostomy. Conclusions Movement disorders caused by strokes have been described in the literature. In their majority, they are secondary to a supratentorial injury. There have been some cases published of infratentorial, unilateral lesions that have caused different types of involuntary movements. More specifically, two papers described tonic spasms seen in pontine strokes. To our knowledge, this is a novel description of a case of bilateral pontine ischemic stroke that causes painful tonic spasms associated with decerebrate rigidity or posturing. Our hypothesis is that given the localization of the strokes in the anterior area of the inferior segment of the pons there may be involvement of the corticospinal, corticobulbar, and rubrospinal tracts which may be responsible for this presentation. Posterior circulation strokes can be missed about 9–14% of the time, possibly due to atypical presentations. We believe that presenting this case can help to improve the current available literature on this topic.

Analysis of prognostic factors in patients with self-expandable metallic stents for treatment of malignant gastric outlet obstruction

Background and aim Self-expandable metallic stents (SEMSs) are widely accepted as a less-invasive treatment for malignant gastric outlet obstruction (GOO). However, the factors related to prognosis and stent dysfunction after SEMS placement are not well known, and we aimed to investigate them. Methods This was a single-center retrospective cohort study of 212 malignant strictures in 207 patients. Factors related to prolonged overall survival (OS) and time to recurrent GOO (TRGOO) after SEMS placement were evaluated. Results Improvement of oral intake was confirmed in 179 patients (86%). The median OS was 65 days. A Cox proportional hazards model revealed that lower cancer stage, lower performance status score at the time of SEMS placement, and administration of chemotherapy after SEMS placement were significant predictive factors for prolonged OS. The median OS was 182 days in the group of SEMS followed by chemotherapy (group A) and 43 days in the group of SEMS alone (group B) (p< .0001). Chemotherapy after SEMS implantation contributed to the prolongation of survival in gastric cancer (hazard ratio (HR), 0.12) and pancreatic cancer (HR, 0.41). Furthermore, the cumulative incidence rates of stent dysfunction on day 120 after SEMS placement were 30% in group A and 61% in group B (p=.03). Notably, the preventive effect of chemotherapy on stent dysfunction was significant in pancreatic cancer. Conclusions SEMS is a treatment with high technical and clinical success rate for malignant GOO. Furthermore, subsequent chemotherapy prolongs OS especially in gastric cancer, and TRGOO in pancreatic cancer.

Survival analysis of a prospective multicenter observational study on surgical palliation among patients with malignant bowel obstruction caused by peritoneal dissemination of gastric cancer.

Our previous report showed that surgical palliation maintained quality of life (QOL), improved solid food intake, and had an acceptable surgical safety among patients with malignant bowel obstruction (MBO) caused by advanced gastric cancer. This study performed a survival analysis stratified by the patients' QOL to elucidate its impact on survival. Patients who underwent resection or bypass of the small intestine/colon or ileostomy/colostomy for bowel obstruction caused by peritoneal dissemination of gastric cancer were included. Validated instruments (EuroQoL-5 Dimensions) were used to assess QOL at baseline and 2weeks, 1month, and 3months following surgical palliation. Postoperative improvement in oral intake was also evaluated using the Gastric Outlet Obstruction Scoring System (GOOSS). Univariate and multivariate survival analyses were performed using baseline characteristics and changes in QOL and GOOSS scores 2weeks after surgery to determine prognostic factors. We enrolled 60 patients with a median survival time of 6.64 (95% CI 4.76-10.28) months. Patients who received postoperative chemotherapy and had lower baseline C-reactive protein (CRP) levels, higher baseline albumin levels, better baseline EuroQoL-5 Dimensions (EQ-5D) scores, and improved oral intake after palliative surgery exhibited significantly better survival. Multivariate analysis identified postoperative chemotherapy, lower baseline CRP levels, and improved oral intake as independent prognostic factors. The current study revealed that baseline QOL and postoperative QOL changes did not affect survival. Moreover, improved oral intake, lower baseline CRP levels, and postoperative chemotherapy were significant prognostic factors in patients who underwent palliative surgery for advanced gastric cancer with MBO.

Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial

We hypothesized that sucralfate along with oral analgesics (acetaminophen or ibuprofen) administered in the emergency department leads to a clinically significant improvement in oral intake in children with acute infectious oral ulcers. This was a randomized, double-blind, placebo-controlled trial of sucralfate versus placebo conducted between 2017 and 2018 in an urban pediatric emergency department. Children aged 6 months to 5 years with acute, infectious oral ulcers and poor oral intake received either acetaminophen at 15 mg/kg or ibuprofen at 10 mg/kg and were then randomized to receive sucralfate at 20 mg/kg per dose up to 1 g or a placebo solution. The primary outcome was oral fluid intake within 60 minutes of medication administration. The secondary outcomes were repeat ED visits, length of stay in ED, intravenous hydration rate, admission rate, adverse event rate, and emergency physician's determination of the adequacy of oral intake. One hundred subjects with mild dehydration (clinical dehydration score of 1) and a median age of 1.38 years were enrolled and analyzed (49 in the sucralfate group and 51 in the placebo group). Oral intake 1 hour after drug administration was similar in both the groups: the median intake in the sucralfate group was 9.7 mL/kg and 10.7 mL/kg in the placebo group (difference -1 mL/kg; 95% confidence interval [CI]-2.0 to 4.8). According to the emergency physician's report, the secondary outcomes were significant only for adequate oral intake: 71% in the sucralfate group versus 88% in the placebo group (difference-16.8%; 95% CI-32.2 to-1.4). Sucralfate as an adjunct to oral analgesics was not superior to placebo in improving oral intake in children with acute oral infectious ulcers.

QOL assessment after palliative surgery for malignant bowel obstruction caused by peritoneal dissemination of gastric cancer: a prospective multicenter observational study.

Patients with peritoneal dissemination of gastric cancer have poor oral intake caused by malignant bowel obstruction (MBO). Palliative surgery has often been undertaken to improve quality of life (QOL), but few prospective studies on palliative surgery in this patient population have been published. We prospectively investigated the significance of palliative surgery using patient-reported QOL measures. Patients underwent palliative surgery by small intestine/colon resection or small intestine/colon bypass or ileostomy/colostomy for MBO. The primary endpoint was change in QOL assessed at baseline, 14days, 1month, and 3months following palliative surgery using the Euro QoL Five Dimensions (EQ-5D™) questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire gastric cancer module (QLQ-STO22). Secondary endpoints were postoperative improvement in oral intake and surgical complications. Between April 2013 and March 2018, 63 patients were enrolled from 14 institutions. The mean EQ-5D™ utility index baseline score of 0.6 remained consistent. Gastric-specific symptoms mostly showed statistically significant improvement from baseline. Forty-two patients (67%) were able to eat solid food 2weeks after palliative surgery and 36 patients (57%) tolerated it for 3months. The rate of overall morbidity of ≥ grade III according to the Clavien-Dindo classification was 16% (10 patients) and the 30-day postoperative mortality rate was 3.2% (2 patients). In patients with MBO caused by peritoneal dissemination of gastric cancer, palliative surgery did not improve QOL while improving solid food intake, with an acceptable postoperative morbidity and mortality rate.

Survival analysis of a prospective multicenter observational study on surgical palliation among patients receiving treatment for malignant gastric outlet obstruction caused by incurable advanced gastric cancer

We had previously reported that surgical palliation could maintain quality of life (QOL) while improving solid food intake among patients with malignant gastric outlet obstruction (GOO) caused by advanced gastric cancer. The present study aimed to perform a survival analysis according to the patients' QOL to elucidate its impact on survival. Patients with GOO who underwent either palliative gastrectomy or gastrojejunostomy were included in this study. A validated QOL instrument (EQ-5D) was used to assess QOL at baseline and 2weeks, 1month, and 3months following surgical palliation. Postoperative improvement in oral intake was also evaluated using the GOO scoring system (GOOSS). Thereafter, univariate and multivariate survival analyses were performed to determine independent prognostic factors. The median survival time of the 104 patients included herein was 11.30months. Patients who received postoperative chemotherapy, PS 0/1, baseline EQ-5D ≥ 0.75, improved or stable EQ-5D, and improved oral intake expressed as GOOSS = 3 had significantly better survival. Multivariate analysis identified postoperative chemotherapy, a better baseline PS, a better baseline EQ5D, improved or stable EQ5D scores, and improved oral intake 3months after surgical palliation as independent prognostic factors. Apart from preoperative PS and postoperative chemotherapy, the present study identified better baseline QOL, improvement in postoperative QOL, and improvement in oral intake as prognostic factors among patients who underwent palliative surgery for advanced gastric cancer with GOO.

Clinical impact of oral intake on second-line treatment of advanced gastric cancer.

e16560 Background: Trifluridine/tipiracil, an oral drug, was approved in Japan for patients (pts) with advanced gastric cancer (AGC). Insufficient oral intake (INSUF) is one of the most common complications. We evaluated the clinical characteristics and impact of oral intake during 2nd line chemotherapy (CT). Methods: We retrospectively evaluated AGC pts receiving 2nd line CT from January 2012 to December 2018 at a single institution. We defined “INSUF” as a requirement for daily intravenous fluids or hyperalimentation and “improvement of oral intake (IMP)” as no such requirement for &gt; 1 week. Exacerbation (EXA) was defined as a change from “sufficient oral intake (SUF)” to INSUF. Results: We enrolled 495 pts, of which 67 (13%) and 428 (87%) pts had INSUF and SUF at the start of 2nd line CT, respectively. Patient characteristics are summarized in the Table. There was no difference in the cytotoxic drugs of 2nd line CT. The causes of INSUF were peritoneal metastases (79%), cachexia (15%), and primary complications (3%). The objective response rates of INSUF and SUF pts were 9% and 26%, respectively. INSUF pts had poorer progression-free survival (PFS) (1.7 vs. 3.7 months [M]; adjusted HR [aHR], 1.51; p &lt; 0.001) and overall survival (3.2 vs. 10.1 M; aHR, 2.01; p &lt; 0.001) than SUF pts. At the end of 2nd line CT, 147 (32%) and 314 (68%) pts had INSUF and SUF, respectively. In SUF pts, the factors correlated with EXA were poor ECOG PS (odds ratio [OR], 5.26; p &lt; 0.001), massive or moderate ascites (OR, 2.04; p = 0.031), palliative operation history (OR, 2.90; p = 0.007), and ramucirumab use (OR, 0.50; p = 0.034). Median PFS was shorter after CT in pts with EXA than in those without (1.7 vs. 4.2 M; aHR, 2.05; p &lt; 0.001). Among INSUF pts, 11 pts (16%) achieved IMP; the rate of IMP did not differ according to regimen. Median PFS was shorter in pts without IMP than in pts with IMP (1.1 vs. 3.3 M; aHR, 4.97; p = 0.001). Subsequent CT was administered to 29% and 71% of INSUF and SUF pts, respectively. Conclusions: INSUF at the start of 2nd line CT was a poor prognostic factor. For appropriate use of oral drugs, CT should be changed in SUF pts with factors associated with EXA. [Table: see text]

The effects of promoting oral intake using the Kuchi-kara Taberu index, a comprehensive feeding assistant tool, in older pneumonia patients: a cluster randomized controlled trial

BackgroundThe multidisciplinary comprehensive care (MDCC) program promotes the improvement of oral intake for older patients. The Kuchi-kara Taberu (ingesting orally in Japanese, KT) index was developed to objectively assess patient conditions in the MDCC program. This trial examined the effects of the index in promoting oral intake in older patients with pneumonia.MethodsA cluster randomized controlled trial was conducted in 10 local hospitals targeting older patients with pneumonia (≥65 years). Ten hospitals were allocated randomly to either the intervention or the control group. Both groups (each with five hospitals) received the MDCC program for oral feeding, which consisted of professional assessment, care, and treatment. The KT index was used by the intervention group, focusing on improving low score items. The primary outcome was determined using the Functional Oral Intake Scale (FOIS) at discharge or 1 month after admission.ResultsOne hundred and twelve patients (46 women and 66 men) who participated from 10 hospitals, with a median age of 88 years (interquartile range [IQR], 80–91), were examined. The median FOIS level and the number of patients with oral intake (FOIS ≥ level 4) at discharge were 4 (IQR, 4–6) and 89 (79.5%), respectively. The duration of nil per os was 2 (IQR, 1–5) days. Clusters were not matched in the presence of Kuchi-kara Taberu Shiawase-wo Mamoru-kai-certified medical staff promoting oral intake in patients with dysphagia in each hospital. The median FOIS levels of 53 patients in the intervention group and 59 patients in the control group were 5 (IQR, 4–6) and 4 (IQR, 4–5), respectively, showing no statistically significant difference (P = 0.76). According to a multivariate analysis, the KT index had no positive effect on FOIS levels.ConclusionsThis trial was not able to demonstrate the usefulness of the KT index due to random assignment failure. However, both the intervention and control groups showed a high prevalence of oral intake (FOIS ≥ level 4) at discharge.Trial registrationUMIN-Clinical Trial Registry, UMIN000025172, December 17, 2016.

Relationship between oral intake and severity of Acute Stroke.

To correlate stroke severity with oral intake level of the studied population and compare the two factors at the time of admission and after swallowing management. A total of 137 patients hospitalized in the cerebral vascular accident unit (CVAU) of a teaching hospital participated. During the stay at CVAU, the patients were submitted to daily neurological evaluation and application of National Institutes of Health Stroke Scale (NIHSS), to evaluate the severity of stroke, ranging from zero (without evidence of neurological deficit) to 42 (in coma and unresponsive). Functional Oral Intake Scale (FOIS), which is a marker for evolution of oral intake and ranges from level one (nothing oral) to seven (oral total restrictions). Data from the NIHSS and FOIS scales of admission and discharge were analyzed and compared to verify association between improvement of oropharyngeal dysphagia with functional improvement of individuals. At admission, 63 (46.0%) patients had mild strokes, 38 (27.7%) had severe and very severe stroke; 46 (33.6%) had oral intake and need for special preparation or compensations. At discharge, there was an increase in patients with mild stroke (76 - 55.5%); oral intake without special preparation or compensations, but with food restrictions (18 - 13.1%), and oral intake without restrictions (44 - 32.1%). The level of oral intake increased as the severity of stroke decreased. Speech and language therapy contributed to a decrease in stroke severity and improvement in oral intake.

Multicenter prospective observational study of QoL after palliative surgery for patients with bowel obstruction caused by peritoneal dissemination of gastric cancer.

90 Background: Patients with peritoneal dissemination of gastric cancer have poor oral intake caused by bowel obstruction. Palliative surgery has often been undertaken to improve quality of life (QoL), but there is no prospective study on palliative surgery. Methods: We prospectively examined the significance of palliative surgery for patients with poor oral intake caused by peritoneal dissemination of gastric cancer using a patient-reported QoL measures. Eligibility criteria included histologically proven primary gastric adenocarcinoma presenting with bowel obstruction caused by peritoneal dissemination; presence of non-curable factors; extremely poor or no oral intake requiring parenteral nutrition. Patients underwent palliative surgery by small intestine/colon resection, small intestine/colon bypass or ileostomy/colostomy for bowel obstruction. The primary endpoint was change in QoL assessed at baseline, 14 days, 1 month and 3 months following surgical palliation by means of the Euro QoL Five Dimensions (EQ-5D) questionnaire and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire gastric cancer module (QLQ-STO22). Secondary endpoints were postoperative improvement in oral intake and surgical complications. Results: Between May 2013 and March 2018, 63 patients (33 bypass and 28 stoma, 3 exploratory laparotomy) were enrolled from 14 institutions. The mean EQ-5D utility index baseline score of 0.6 remained consistent. Gastric-specific symptoms mostly showed statistically significant improvement from baseline. 42 patients (67%) were able to eat solid food 2 weeks after palliative surgery and 36 patients (57%) tolerated it for 3 months. The rate of overall morbidity of grade III or more according to the Clavien–Dindo classification was 15.8 per cent (10 patients) and the 30-day postoperative mortality rate was 3.2 per cent (2 patients). Conclusions: In patients with bowel obstruction caused by peritoneal dissemination of gastric cancer, palliative surgery maintained QoL while improving solid food intake, with acceptable operative morbidity and mortality rate. Clinical trial information: 000023495.

Modified FOLFOX6 as a first-line treatment for patients with advanced gastric cancer with massive ascites or inadequate oral intake.

BackgroundOral fluoropyrimidine plus platinum is a standard first-line treatment for advanced gastric cancer (AGC). However, this treatment is problematic for AGC patients with massive ascites or inadequate oral intake. This study aimed at evaluating the efficacy and safety of modified oxaliplatin (L-OHP) with l-leucovorin (l-LV) and bolus/continuous infusion of 5-fluorouracil (5-FU) (mFOLFOX6) regimen for patients with massive ascites or inadequate oral intake.MethodsThis retrospective study was conducted at a single Japanese institute from November 2015 to May 2018. The mFOLFOX6 regimen consisted of 85 mg/m2 L-OHP, 400 mg/m2 bolus of 5-FU, and 400 mg/m2 1-LV on the first day, followed by 2,400 mg/m2 of 5-FU as a continuous infusion in 46 hours for first-line treatment. The definition of inadequate oral intake was the need for total parenteral nutrition (TPN). Massive ascites was defined as continuous ascites from the pelvic cavity to the upper abdomen. Improvement in oral intake was defined as no TPN for more than 7 days, and improvement in ascites was defined as a decrease in ascites of more than one grade defined by the Japan Clinical Oncology Study Group trial (JCOG0106).ResultsAmong the 364 patients with AGC who received first-line chemotherapy, 17 patients (13 [76.5%] had inadequate oral intake, and four [23.5%] had massive ascites) were enrolled in this study. Median time to treatment failure and overall survival were 4.8 (95% CI=1.5–7.5) and 8.8 months (95% CI=2.3–not available), respectively. Objective improvements in oral intake and ascites were seen in 11 of 13 patients (84.6%) and 6 of 12 patients (50%), respectively. The major grade 3 or 4 adverse events were neutropenia (35.3%), febrile neutropenia (5.9%), fatigue (5.9%), anorexia (5.9%), and infection (5.9%). No treatment-related deaths occurred.ConclusionWe found that mFOLFOX6 can be a novel treatment option as the first-line treatment for AGC patients with massive ascites or inadequate oral intake.

PS02.156: IMPROVING COMPLIANCE WITH ENHANCED RECOVERY PROTOCOLS IN OESOPHAGO-GASTRIC CANCER SURGERY: A COLLABORATIVE QUALITY IMPROVEMENT PROJECT

Abstract Background Compliance with enhanced recovery programmes (ERPs) in oesophago-gastric (OG) surgery is challenging due to high rates of complications. Higher compliance is associated with better outcomes; however compliance is difficult to assess due to variable reporting and lack of standardisation of descriptors within an ERP. This study aims to understand variability in ERPs across two OG cancer centres and analyse impact of cross-site engagement and collaborative quality improvement (QI) on ERP compliance. Methods The collaborative QI project consisted of workshops and meetings that involved presentations and assessment of variations across ERPs, with prospective recording of ERP compliance at each site and cross-site feedback of results. Compliance and outcomes for 2016 were compared with 2017 to assess impact of QI initiative. Results At site A, overall mobilisation improved from 25% to 28% (P = 0.448) and oral intake from 19% to 56% (P = 0.002). There were no improvements in NGT (65% to 54%) and drain removal (69% to 53%). At site B, mobilisation improved from 51% to 68% (P = 0.097), NGT removal from 37% to 51% (P = 0.196), and drain removal from 15% to 32% (P = 0.412). There was no improvement in oral intake (47% to 34%). At site A, all complications reduced from 56% to 46% (P = 0.401), pneumonia from 47% to 22% (P = 0.024), and grade 3 complications from 22% to 15% (P = 0.605). At site B, all complications reduced from 58% to 54% (P = 0.697), pneumonia from 46% to 37% (P = 0.353), and grade 3 complications from 23% to 20% (P = 0.678). At site A, the median length of hospital stay reduced from 11 days to 9 days (P = 0.024), with no improvement at site B (12 to 14 days). Conclusion Engagement between clinical teams across the two sites resulted in improvement in postoperative outcomes. Compliance with individual ERP elements was observed across a few domains. Challenges encountered in this project included a lack of standardised definitions of ERP descriptors, variability in measures and variations in the individual elements within each ERP. Disclosure All authors have declared no conflicts of interest.

Multicentre observational study of quality of life after surgical palliation of malignant gastric outlet obstruction for gastric cancer.

BackgroundQuality of life (QoL) is a key component in decision‐making for surgical palliation, but QoL data in association with surgical palliation in advanced gastric cancer are scarce. The aim of this multicentre observational study was to examine the impact of surgical palliation on QoL in advanced gastric cancer.MethodsThe study included patients with gastric outlet obstruction caused by incurable advanced primary gastric cancer who had no oral intake or liquid intake only. Patients underwent palliative distal/total gastrectomy or bypass surgery at the physician's discretion. The primary endpoint was change in QoL assessed at baseline, 14 days, 1 month and 3 months following surgical palliation by means of the EuroQoL Five Dimensions (EQ‐5D™) questionnaire and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire gastric cancer module (QLQ‐STO22). Secondary endpoints were postoperative improvement in oral intake and surgical complications.ResultsSome 104 patients (23 distal gastrectomy, 9 total gastrectomy, 70 gastrojejunostomy, 2 exploratory laparotomy) were enrolled from 35 institutions. The mean EQ‐5D™ utility index scores remained consistent, with a baseline score of 0·74 and the change from baseline within ± 0·05. Gastric‐specific symptoms showed statistically significant improvement from baseline. The majority of patients were able to eat solid food 2 weeks after surgery and tolerated it thereafter. The rate of overall morbidity of grade III or more according to the Clavien–Dindo classification was 9·6 per cent (10 patients) and the 30‐day postoperative mortality rate was 1·9 per cent (2 patients).ConclusionIn patients with gastric outlet obstruction caused by advanced gastric cancer, surgical palliation maintained QoL while improving solid food intake, with acceptable morbidity for at least the first 3 months after surgery. Registration number 000023494 (UMIN Clinical Trials Registry).

A prospective multicenter observational study of surgical palliation examining postoperative quality of life in patients treated for malignant gastric outlet obstruction caused by incurable advanced gastric cancer.

6 Background: Decision-making for surgical palliation remains one of the most challenging clinical scenarios since quality of life (QOL) is a key component of cancer care. We conducted this study to examine the impacts of surgical palliation on postoperative QOL in patients (pts) with malignant gastric outlet obstruction (GOO) caused by incurable primary gastric cancer (GC). Methods: Eligibility included (1) no oral intake or liquids only requiring parenteral nutrition (2) aged ≥20 (3) surgically fit (4) ECOG PS of 0-2 and (5) written IC. Patients underwent either palliative distal/total gastrectomy (DG/TG) or gastrojejunostomy (GJS). Treatment choice was left to the discretion of the physician. Validated QOL instruments (EORTC QLQ-STO22 and EuroQol-5D) assessed QOL at baseline, 2 weeks (wks), 1 month (m), and 3 months following the surgical palliation, and two observational outcomes (postoperative improvement of oral intake, and safety of surgical intervention) were evaluated. Results: 104 pts, 71 males and 33 females with a median age of 68 years, were enrolled. The types of surgery were DG in 23 pts, TG in 9 pts, GJS in 70 in pts, and exploratory laparotomy in 2 pts. Baseline QOL questionnaires were completed by 103 (99.0%) pts. Among the 104 pts, 98 (94.2%), 100 (96.1%), and 81 (77.9%) completed the 2-wk, 1-m, and 3-m follow-up survey, respectively. The mean baseline EQ-5D score was 0.74 (SD, 0.21). During the follow-up period, the mean scores remained consistent with the baseline scores; the change from baseline score was within ± 0.05 for the index. Many pts came to eat solid food at 2 wks postsurgery and remained tolerable thereafter (from 0 at baseline to 82, 85, 75 pts at 2 wks, 1 m, and 3 ms, respectively). Overall morbidity rate of ≥grade 3 on Clavien-Dindo classification and 30-day postoperative mortality rate was 9.6% (10 pts) and 2.0% (2 pts) with a median hospital stay of 13 days and re-operation rate of 3.9% (4 pts). Conclusions: In pts with malignant GOO caused by advanced GC, surgical palliation maintained patient QOL while improving solid food intake with an acceptable surgical safety. Clinical trial information: UMIN000023494.

Laparoscopic gastrojejunostomy versus duodenal stenting in unresectable gastric cancer with gastric outlet obstruction.

PurposeTo compare the outcome between laparoscopic gastrojejunostomy (LapGJ) and duodenal stenting (DS) in terms of oral intake, nutritional status, patency duration, effect on chemotherapy and survival.MethodsMedical records of 115 patients, who had LapGJ or duodenal stent placement between July 2005 and September 2015 in Seoul National University Bundang Hospital, have been reviewed retrospectively. Oral intake was measured with Gastric Outlet Obstruction Scoring System. Serum albumin and body weight was measured as indicators of nutritional status. The duration of patency was measured until the date of reintervention. Chemotherapy effect was calculated after the procedures. Survival period and oral intake was analyzed by propensity score matching age, sex, T-stage, comorbidities, and chemotherapy status.ResultsForty-three LapGJ patients and 58 DS patients were enrolled. Improvement in oral intake was shown in LapGJ group versus DS group (88% vs. 59%, P = 0.011). Serum albumin showed slight but significant increase after LapGJ (+0.75 mg/dL vs. −0.15 mg/dL, P = 0.002); however, there was no difference in their body weight (+5.1 kg vs. −1.0 kg, P = 0.670). Patients tolerated chemotherapy longer without dosage reduction after LapGJ (243 days vs. 74 days, P = 0.006) and maintained the entire chemotherapy regimen after the procedure longer in LapGJ group (247 days vs. 137 days, P = 0.042). LapGJ showed significantly longer survival than DS (220 vs. 114 days, P = 0.004).ConclusionDS can provide faster symptom relief but LapGJ can provide improved oral intake, better compliance to chemotherapy, and longer survival. Therefore, LapGJ should be the first choice in gastric outlet obstruction patients for long-term and better quality of life.

Efficacy of chemotherapy after self-expanding metal stent placement for gastric outlet obstruction caused by an unresectable malignant tumor.

484 Background: Gastric outlet obstruction (GOO) is a late complication of advanced and metastatic malignant tumors. Self-expanding metal stent (SEMS) placement is a safe and effective palliative treatment for patients with GOO. In general, the median survival time after SEMS placement for GOO is approximately 90 days, and advanced chemotherapeutic treatment could further improve prognosis. Methods: This retrospective study aimed to analyze the efficacy of chemotherapy after SEMS placement on improvement of oral intake and survival time. Eight patients with symptomatic malignant GOO were treated by SEMS placement in our hospital. Surgical bypass could not be performed due to severe advanced malignant tumors. Patients were classified into two groups depending on whether they received chemotherapy after SEMS placement. Group A included five patients who were treated with palliative therapy alone (median age: 72 years; cases 1, 2, 3, and 4 with advanced gastric cancer, and case 5 with advanced pancreatic carcinoma). Group B included three patients who were treated with palliative therapy, followed by chemotherapy (median age: 68 years; case 6 with advanced pancreatic cancer treated with gemcitabine chemotherapy; case 7 with advanced gastric carcinoma treated with TS-1 and paclitaxel chemotherapy; and case 8 with duodenal stenosis due to advanced colonic carcinoma treated with irinotecan and cetuximab chemotherapy after SEMS placement). We estimated the gastric outlet obstruction scoring system (GOOSS ; no oral intake: 0; only liquids: 1; soft solids: 2; low-residue or full diet: 3) and survival time as the main outcomes. Results: SEMS placement using endoscopy was successful in all cases. No complications occurred after the procedure. Performance status did not change after SEMS placement. GOOSS improved from 0 to 1 in group A and from 0 to 2 in group B. Median survival time was 68 days in group A and 188 days in group B. We considered chemotherapy after SEMS contributed lifetime. Conclusions: Our study findings indicate that SEMS placement is a safe and effective method for managing malignant GOO and that chemotherapy after SEMS placement can improve diet intake and prognosis.

Outcomes of endoscopic pyloric stenting in malignant gastric outlet obstruction: a retrospective study

BackgroundUp to 30% of patients with pancreatic cancer and more than 50% of patients with gastric cancer already have incurable disease, with distressing symptoms of gastric outlet obstruction at the time of presentation which require effective palliation. We decided to test the clinical outcomes of endoscopic stent placement in malignant gastric outlet obstruction.MethodsIn a retrospective single institution-based study, the charts of patients who had self-expandable metal stents placed to alleviate malignant gastric outlet obstruction were reviewed. Charts were reviewed to assess improvement in oral intake according to the Gastric Outlet Obstruction Scoring System (GOOSS), and in order to also evaluate technical success and complications of the procedure.Results69 patients with successful stent placement were retrospectively evaluated. Within 7 and 28 days after stent placement respectively, 85.5% and 80% benefited from stent insertion, with an increase in the GOOSS score of > 1. Resumption of soft or low residue diet (GOOSS 2-3) was achieved in 53.6% at day 7 and in 62% of patients at day 28, respectively. Of the patients achieving a GOOSS score of 2-3, 17.3% remained on a soft or low residue diet at 24 weeks or at last follow up, while 46% died. Stent related adverse events occurred in 10 patients (14%), including stent blockade in 7 and stent migration in 3 patients.ConclusionEndoscopic enteral stenting promptly increases oral intake in the majority of patients with malignant gastric outlet obstruction and is a safe procedure with a low rate of serious complications.

Sa1488 A Retrospective Review of Self-Expandable Metallic Stents and Gastrojejunostomy for Malignant Gastric Outlet Obstruction

Self-expandable metallic stent (SEMS) placement is performed as an alternative to gastrojejunostomy (GJ) for the palliation of malignant gastric outlet obstruction (GOO). Clinical outcomes and adverse events are still unclear. In order to assess the clinical outcomes of SEMS placement and GJ, we conducted a retrospective review according to improvement in oral intake (based on the GOO scoring system [GOOSS]), survival time, resumption of chemotherapy, and complications, respectively.

Efficacy and safety of a WallFlex enteral stent for malignant gastric obstruction

The aim of the present study was to investigate the efficacy and safety of a newly available enteral WallFlex stent for malignant gastric outlet obstruction (GOO). Twenty-one consecutive patients with symptomatic (unable to take solids) malignant GOO treated by a WallFlex stent from April 2010 to February 2012 were included and analyzed retrospectively. Main outcome measurements were technical success, early complications, clinical response (elimination of the need for nasogastric tube drainage), clinical success (improvement of oral intake to a GOO score of 2 or 3), and duration of sustaining a GOO score of 2 or 3 after clinical success (median duration until reworsening of GOO score to <2 by the Kaplan-Meier method). A four-point GOO scoring system (0-3) was used for estimation of oral intake. Technical success rate was 100%. Bleeding and perforation after stent placement and stent dislocation/migration in the follow-up period did not occur in any patients, whereas one patient (5%) developed moderate post-procedural pancreatitis. Clinical response and clinical success was achieved in all patients and in 81% (17/21), respectively. In 17 patients whose GOO score had improved to 2 or 3 after stent placement, eight (47%) developed reworsening of the GOO score to <2 with a median time of 148 days (95% confidence interval [CI], 0-328; Kaplan-Meier method). Median survival time after the initial intervention was 61 days (95% CI, 40-82). Placement of an enteral WallFlex stent in patients with malignant GOO is safe and effective.