Esophageal Cancer Surgery Research Articles

A case of intraoperative detection of a central venous catheter in azygos vein arch during esophageal cancer surgery

Abstract Background Central venous catheter (CVC) is often used in the perioperative management of esophageal cancer. The position of the CVC tip has been reported to shift with body positioning and, although infrequent, may traverse into the azygos vein arch. Herein, we describe a case where a migrated CVC tip in the azygous vein arch was identified during esophageal cancer surgery, preventing CVC dissection concurrent with azygous vein arch resection. Case presentation A 65-year-old man was diagnosed with advanced esophageal cancer and was referred to our department for surgery after undergoing neoadjuvant chemotherapy. He underwent robot-assisted subtotal esophagectomy, followed by gastric conduit reconstruction via the posterior sternal route. Thoracic manipulation was performed with the patient in the prone position. During the surgery, a foreign body was found in the azygos vein arch, indicating that a central venous catheter had inadvertently entered the azygos vein arch. The catheter was retracted by 5 cm, and after confirming that no catheter remained in the azygos arch, the azygos vein arch was separated using an autosuture device. Conclusions Central venous catheter migration can occur in a various vessels. During prone esophageal cancer surgery, elevating the right upper extremity may alter the catheter tip’s position from its the preoperative position. CVC amputation should be observed because the azygos vein arch is often amputated to facilitate upper mediastinal dissection during esophageal cancer surgery.

Advantages of the split-leg supine position single-port plus one laparoscopic surgery approach

The goal of this study was to compare the advantages of conventional laparoscopic surgery (CLS) and the split-leg supine position single-port plus one laparoscopic surgery (SSP SILS + 1) in esophageal surgery. This study enrolled 73 patients who previously underwent radical esophagectomy for esophageal cancer from August 2021 to February 2023. Among them, 36 patients underwent SSP SILS + 1, whereas the remaining 37 patients underwentCLS. Surgical time, bleeding volume, number of dissected lymph nodes, incision length, and postoperative abdominal pain score between the two groups of patients were compared using either the Student’s t-test or chi-square test. Time of abdominal incision (1.4 ± 0.2 min vs. 5.2 ± 0.7 min, p < 0.001) was shorter in patients in the SSP SILS + 1 group compared with those in the CLS group. However, the average incision length was shorter in the SSP SILS + 1 group compared with that in the CLS group (35.4 ± 4.0 cm vs. 4.6 ± 4.1 cm, p < 0.001). Notably, the pain score on postoperative day (POD) 1 was lower in the SSP SILS + 1 group compared with that in the CLS group (5.7 ± 0.7 vs.6.3 ± 0.7, p = 0.001). The SCAR score was also lower in the SSP SILS + 1 group compared with that in the CLS group (3.5 ± 0.9 vs. 8.3 ± 1.4, p = 0.019). There was no significant difference in the number of dissected abdominal lymph nodes and positive lymph nodes (p > 0.01) between the two groups. The SSP SILS + 1 intervention offers multiple benefits over conventional surgical procedures, encompassing shorter incision length and pain scores on POD 1. In accelerated rehabilitation surgery for esophageal cancer, this surgical procedure demonstrated high safety, feasibility.

Rehabilitation for complicated dysphagia after synchronous head-and-neck and esophageal cancer surgery: A case report

Rationale: Surgical intervention for synchronous head-and-neck and esophageal cancers often results in complex dysphagia, significantly affecting postoperative quality of life. Swallowing dysfunction may become permanent or worsen, with potential impacts on noncancer-related mortality. Patient concerns: We report a rare case of multiple synchronous squamous cell carcinomas of the head and neck (tonsillar and epiglottic cancer) along with esophageal cancer, presenting for dysphagia rehabilitation following surgery. Diagnoses: Comprehensive evaluations—including magnetic resonance imaging, laryngoscopy, gastroscopy, and histopathology—led to diagnoses of left tonsil cancer (squamous cell carcinoma, T2N2bM0), epiglottic cancer (squamous cell carcinoma, T1N2bM0), and lower esophageal cancer (squamous cell carcinoma, T2N0M0). Postoperative videofluoroscopic swallowing study identified an anastomotic stricture at the level of the fifth cervical vertebra. Interventions: The patient underwent an 8-week rehabilitation program incorporating stretching exercises, swallowing behavior therapy, super-supraglottic swallow techniques, catheter balloon dilation, electrical stimulation, and respiratory therapy. Outcomes: Following rehabilitation, the patient was able to resume partial oral intake without aspiration, with significant improvement in anastomotic stricture and swallowing function. Lessons: This case of dysphagia underscores the anastomotic stenosis resulting from oncological surgical intervention. Dysphagia is a frequent complication in patients with synchronous head-and-neck and esophageal cancers. Comprehensive rehabilitation and assessment of swallowing function enabled safe oral intake postoperatively in this patient.

Intensified outpatient nutrition management improves body weight and skeletal muscle loss after esophageal cancer surgery: a single-center, retrospective, single-arm clinical study

BackgroundThe progression of malnutrition and sarcopenia after esophagectomy for esophageal cancer negatively influences long-term prognosis. To improve nutritional status after esophagectomy, we introduced an intensified nutrition management (iNM) protocol, in which nutritional counselling by dietitians was provided more frequently. The aim of this study was to evaluate the efficacy of iNM compared with the conventional NM (cNM).MethodsWe included 126 patients who underwent esophagectomy before and after NM revision, and compared nutritional status and changes in body composition after esophagectomy between the cNM and iNM groups. Nutritional parameters were assessed, and we also calculated skeletal muscle index (SMI), skeletal muscle density (SMD), and visceral fat area (VFA) using computed tomography volumetry.ResultsThere were no significant differences in baseline characteristics or surgical outcomes between the groups. Compared with the cNM group, nutritional counselling was provided more frequently (P < 0.001) in the iNM group, and compliance rate increased from 56.3 to 91.9% (P < 0.001). Body weight loss at 4 and 6 months and SMI reduction at 6 months were significantly improved in the iNM group compared with the cNM group (P < 0.001, P = 0.032, and P = 0.023, respectively). There were no significant differences in the changes in SMD, VFA, serum albumin level, and prealbumin level between the two groups.ConclusionsOutpatient iNM significantly mitigated the reduction in body weight and SMI 3–6 months after esophagectomy.

Gastro-tracheal fistula following esophageal cancer surgery through the retrosternal route: a case report

BackgroundGastro-tracheal fistula is a rare but serious complication after esophageal surgery, often requiring long-term treatment and invasive procedures. Gastro-tracheal fistula usually occurs through the posterior mediastinal route and rarely through the retrosternal route. No previous reports have described gastro-tracheal fistula after retrosternal route reconstruction was cured by conservative treatment.Case presentationA 70-year-old man with lower thoracic esophageal cancer underwent thoracoscopic esophagectomy in the prone position and gastric tube reconstruction through the retrosternal route with neck anastomosis after neoadjuvant chemotherapy. Despite anastomotic leakage on postoperative day 10, his general condition was stable, and he was managed conservatively with antibiotics and gastric tube decompression. On day 29, he presented with high fever and a gastro-tracheal fistula was observed by esophagography. Conservative management was continued because the patient remained stable. On day 48, esophagography showed that the fistula was undetectable. The patient was able to take fluids orally. He progressed well on an oral diet and was transferred to a different hospital.ConclusionsA gastro-tracheal fistula, although rare, can occur after retrosternal route reconstruction. When a patient is stable, gastro-tracheal fistula after retrosternal route reconstruction may be cured by conservative treatment.

Paraconduit hiatus hernia after esophageal cancer surgery: incidence, risk factors, and management.

In parallel with improved operative and oncologic outcomes for esophageal cancer, paraconduit hiatus hernia (PHH) is an increasingly recognized entity, both in the early postoperative phase and in long-term follow-up. The aim of this study was to assess the incidence of and risk factors for PHH, and to describe management approaches in a tertiary referral center. All patients undergoing surgery with curative intent for esophageal cancer from 2008 to 2022 at a single center were included. Early PHH was defined as occurring within threemonths of index surgery, with all other cases defined as late PHH. Surveillance computed tomography scans were undertaken among all disease-free patients to 5years postoperatively. Kaplan Meier and Cox proportional hazards regression models were used to determine independent risk factors for PHH. Overall, 897 patients were studied. Totally, 62 patients (6.9%) developed PHH during follow-up. The 5-year survival-adjusted incidence of PHH was 9.7%. PHH was an asymptomatic radiologic finding in 45.5% of early and 84.3% of late cases (P =0.070). Surgical intervention was required in 16 cases (25.8%), more commonly following early (63.6%) as compared with late PHH (17.6%, P < 0.01). Younger age (P < 0.039), initial transhiatal operative approach (P < 0.006) and extended resection of the crura (P < 0.001) were independently associated with increased risk of PHH on multivariable analysis. PHH was identified in almost 1 in 10 patients using surveillance imaging in long-term follow-up, independently associated with the transhiatal surgical approach and resection of crura, which raises consideration of prevention strategies. Surgical intervention is often required for patients with PHH presenting early after surgery, but many patients presenting with late PHH may be managed expectantly.

Minimally Invasive Transhiatal Esophagectomy Using Antegrade Inversion Technique in Esophageal Cancer: 10-Year Experience from a Tertiary Care Center.

Background: Esophageal cancer surgery aims for curative intent but carries high complication rates. Transthoracic esophagectomy is the dominant approach, however, transhiatal esophagectomy (THE) offers selective advantages in certain clinical scenarios. Minimally invasive THE (MI-THE) is an evolving technique with limited data. Methods: This retrospective study reviewed 38 patients with esophageal cancer who underwent MI-THE using "Antegrade Inversion Technique" between 2013 and 2023 at a tertiary care center. Perioperative outcomes were analyzed. Data were presented as mean with standard deviation, median with interquartile range, and percentages. Results: Most patients (86.8%) had early-stage cancer. Median operative time was 375 minutes, hospital stay was 8 days, and intensive care unit stay was 3 days. All patients achieved a negative resection margin. Pleural effusion (57.9%) was the most common complication, followed by pneumothorax (31.6%) and surgical site infection (15.8%). Anastomotic leak rate was 13.2%. There was no mortality. Conclusions: MI-THE appears safe and feasible with encouraging perioperative outcomes, particularly for early-stage disease and high-risk patients. While potentially offering advantages over open THE, further research is needed to definitively establish its role compared to traditional approaches.

Conversion surgery for esophageal and esophagogastric junction cancer.

As a result of the recent advances in first-line treatment including chemotherapy, radiation therapy, targeted therapy, and immune checkpoint inhibitor immunotherapy (ICI) for locally advanced/metastatic initially unresectable esophageal and esophagogastric junction cancer, surgery aiming at cure after initial treatment, so-called "conversion surgery" has become more common in this field. Several studies have indicated encouraging survival outcomes for patients after conversion surgery with R0 resection. However, various issues, such the utility and the safety of conversion surgery remain unclear. In this review, we will focus on the surgical treatment for initially unresectable esophageal and esophagogastric junction cancer after first- or later- line treatment and review recent evidence regarding the safety and the efficacy of conversion surgery. Multidisciplinary treatment including surgery may serve as a novel treatment strategy for esophageal and esophagogastric junction cancer, thus provide a curative treatment option and potentially contribute to better prognosis for initially untreatable diseases.

Endoscopic ultrasound-guided drainage for mediastinal abscess: first report of bridge to surgery for esophageal cancer.

Perforated esophageal cancer rarely results in the formation of mediastinal abscess. Endoscopic ultrasound (EUS)-guided abscess drainage (AD) has increasingly been used in the management of abscesses in locations that are difficult to treat percutaneously. We describe a case of EUS-AD for mediastinal abscess due to perforating esophageal cancer and successful bridge to surgery. A 71-year-old man with suspected esophageal issues was referred to our hospital. Computed tomography showed an esophageal cancer perforating the mediastinum, forming a mediastinal abscess. EUS-AD was planned before curative resection, because there was little improvement in inflammatory response with antimicrobial therapy. The mediastinal abscess cavity was confirmed on EUS and punctured using a 19-G needle, and then, a 0.025-inch guidewire was placed in the abscess cavity. The fistula was dilated with a 7-Fr dilator and a 6-Fr, single-pigtail nasobiliary tube was placed in the abscess cavity. One month later, clinical signs had improved and curative surgery was performed. Postoperative adjuvant therapy was administered using fluorouracil/cisplatin therapy. As of 2years postoperatively, the patient remains free of recurrence.

Robot-assisted minimally invasive esophagectomy for esophageal cancer in the left lateral decubitus position.

The use of robot-assisted minimally invasive esophagectomy (RAMIE) in the prone position for esophageal cancer has been currently increasing worldwide. In future, as surgical-assisted robots become more widespread, it is estimated that only two methods of transthoracic approach will remain: RAMIE and open thoracotomy for thoracic esophageal cancer. RAMIE in the left lateral decubitus position (RAMIE-LLDP) has the same field of view as open thoracotomy, is safe in emergency situations, and provides education on open thoracotomy. Between September 2020 and April 2024, RAMIE-LLDP was performed in 64 consecutive patients with esophageal cancer. RAMIE-LLDP was performed with the operating table rotated and tilted 45° to the ventral side under artificial pneumothorax. The hand-control setting of the surgical-assist robot system was reversed left to right when the Patient Cart was rolled from the same direction as the RAMIE in the prone position. The mean total surgery and console times during the thoracic procedure were 254-min overall and 225min in the last 24 cases and 195-min overall and 178-min in the last 24 cases, respectively. The mean amount of blood loss was 203.4g overall and 28.3g in the last 24 cases. Postoperative recurrent laryngeal nerve palsy with Clavien-Dindo classification (CD) was ≥ 2 in six patients (9.4%). Postoperative pneumonia with CD ≥ 2 was observed in 11 patients (17.2%). Conversion to open thoracotomy was observed in three patients (4.7%). In all three patients, an immediate conversion to thoracotomy without patients' position change was actually possible and no serious complications were noted. No mortality occurred within 30days postoperatively. RAMIE-LLDP which facilitates emergency thoracotomy has perioperative results comparable to those of conventional thoracoscopic esophagectomy and is educational for open surgery. RAMIE-LLDP is the safest and most optimal surgery for esophageal cancer.

Nutritional literacy of patients who underwent surgery for esophageal cancer based on Nutbeam's health literacy model: a qualitative study.

The level of nutritional literacy reflects the self-management ability of individuals for a healthy diet and serves as a foundation for effective nutritional interventions. This qualitative study aimed to gain a comprehensive insight into the nutritional literacy levels of patients with esophageal cancer who underwent surgery, obtaining information from both patients and medical staff through interviews. Based on Nutbeam's health literacy model, 27 participants were selected from December 2023 to February 2024. We used semi-structured interviews and directed content analysis. Sixteen patients who underwent surgery for esophageal cancer and 11 medical staff from the Department of Esophageal Cancer completed the interviews. There were five themes, including attitude and cognition, functional nutrition literacy, interactive nutrition literacy, critical nutrition literacy, and ways to improve patients' nutritional literacy. This study investigated the nutritional literacy levels of patients after esophageal cancer surgery from the perspectives of both patients and medical staff, offering comprehensive insights into the assessment of patients' nutritional literacy and the corresponding strategies for improvement. It emphasizes the hierarchical nature of nutritional literacy among patients after surgery and systematically outlines the different levels of nutritional literacy in this population. The results indicated that the level of nutrient literacy was low and exhibited marked differences. This finding suggests that future studies should be individualized, continuous, and comprehensive, following the Nutbeam's health literacy model, to improve patients' nutritional literacy levels.

Risk Factors for Postoperative Pneumonia in Esophageal Cancer Patients

Purpose Patients undergoing surgery for esophageal cancer (EC) frequently experience postoperative pneumonia (POP). POP promotes poor prognosis as well as increased medical costs and longer hospital stays. Therefore, it is desirable to prevent and strictly control high-risk cases to reduce the incidence of pneumonia. The present study aimed to determine the risk factors for POP in EC. Patients and Methods The subjects of this retrospective study were 151 patients with EC who underwent subtotal esophagectomy in our department between January 2012 and December 2021. Univariate and multivariate logistic regression analyses were used to evaluate the association between the incidence of POP and clinical factors. Results Among 151 patients, 33 cases (21.8%) developed POP. Multivariate analysis identified preoperative C-reactive protein-to-albumin ratio (CAR) ≥0.03 [odds ratio (OR), 2.69; P = 0.0352], chronic obstructive lung disease (COPD) (OR, 7.32; P = 0.0001), and diabetes mellitus (DM) (OR, 3.35; P = 0.0252) as independent risk factors for POP. In accordance with the number of risk factors, the incidence rate of POP drastically increased, and its rate in patients with 3 risk factors was 80%. Conclusion High CAR, COPD, and DM are independent risk factors for the development of POP in patients undergoing subtotal esophagectomy for EC. Clinicians should be aware of the risk factors for POP and consider more intensive preventive measures and postoperative management in patients with EC.

S704 Robotic-Assisted Versus Video-Assisted Minimally Invasive Surgery for Esophageal Cancer: An Updated Systematic Review, Meta-Analysis and Trial Sequential Analysis

S704 Robotic-Assisted Versus Video-Assisted Minimally Invasive Surgery for Esophageal Cancer: An Updated Systematic Review, Meta-Analysis and Trial Sequential Analysis

Relationship between hospital surgical volume and the perioperative esophagectomy costs for esophageal cancer: a nationwide administrative claims database study.

Numerous studies have described positive relationships between hospital volume (HV) and clinical outcomes in highly complex procedures, including esophagectomies. Although the centralization of surgery has been considered a possible solution for improving clinical outcomes, the HV impact on perioperative healthcare costs is unknown. This study aimed to determine the relationship between HV and perioperative healthcare costs for patients undergoing esophagectomy for esophageal cancer. This retrospective, nationwide cohort study used Japanese Administrative Claims Database data. Data on esophagectomies performed nationwide in 2015 were extracted. The outcome measure was perioperative healthcare costs per person from the perspective of the insurer. The healthcare costs in outpatient or inpatient settings of any hospital and clinic where patients received treatment were summed up from the month the surgery was performed to 3months after. Linear regression analyses were conducted to assess the risk-adjusted effects of the HV category (1-4/5-9/10-14/15-) on perioperative costs. A total of 5232 patients underwent an esophagectomy at 584 hospitals. The overall perioperative cost was 20.834 billion Japanese yen (JPY). The median perioperative costs per person for each HV category (1-4/5-9/10-14/15-) were 3.728 (709 patients), 3.740 (658 patients), 3.760 (512 patients), and 3.760 (3253 patients) million JPY, respectively (P = 0.676). Multivariate analyses revealed that each HV category had no significant impact on perioperative costs. There were no significant differences in the perioperative costs between high- and low-volume centers. Esophageal cancer surgery centralization may be achievable without increasing healthcare costs.

Effects of three-dimensional quality assessment nursing intervention on efficacy and disease management of patients undergoing esophageal cancer surgery.

Esophageal cancer is one of the most common malignant tumors. The three-dimensional quality structure model is a quality assessment theory that includes three dimensions: Structure, process, and results. To investigate the effects of nursing interventions with three-dimensional quality assessment on the efficacy and disease management ability of patients undergoing esophageal cancer surgery. In this prospective study, the control group received routine nursing, and the intervention group additionally received a three-dimensional quality assessment intervention based on the above routine care. Self-efficacy and patient disease management abilities were evaluated using the General Self-Efficacy Scale (GSES) and Exercise of Self-Care Agency scale, respectively. IBM SPSS Statistics for Windows, version 17.0, was used for the data processing. This study recruited 112 patients who were assigned to the control and experimental groups (n = 56 per group). Before the intervention, there was no significant difference in GSES scores between the two groups (P > 0.05). After the intervention, the GSES scores of both groups increased, with the experimental group showing higher values (P < 0.05). At the time of discharge and three months after discharge, the scores for positive attitudes, self-stress reduction, and total score of health promotion in the experimental group were higher than those in the control group (P < 0.05). The implementation of a three-dimensional quality structure model for postoperative patients with esophageal cancer can effectively improve their self-management ability and self-efficacy of postoperative patients.

Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery (EPITOPE): an open-label, randomized, parallel-group pilot study.

Chronic obstructive pulmonary disease (COPD) is a risk factor for pneumonia following esophagectomy. This study aimed to investigate the efficacy of perioperative inhaled tiotropium in patients with COPD undergoing esophagectomy. This open-label, randomized controlled trial randomly assigned 32 patients with COPD undergoing esophagectomy to conventional management or addition of tiotropium inhalation. The intervention group received tiotropium from two weeks before esophagectomy until the final evaluation one month after esophagectomy. The primary outcome was the incidence of pneumonia within 30 postoperative days. We also assessed the changes and the percentages from baseline in pulmonary function and walking distance of the incremental shuttle walking test to just before esophagectomy and final evaluation. Enrolled patients were randomly assigned to the control group (n = 18) and the intervention group (n = 14). Pneumonia was recorded in 4 (28.6%) and 5 (27.8%) patients in the intervention and control groups, respectively (risk difference: 0.8%, 95% confidence interval: - 30.6 to 32.2). The intervention group demonstrated a significant improvement in pulmonary function and walking distance preoperatively. Further, the pulmonary function test was significantly better preoperatively in the intervention group than in the control group. Postoperatively, pulmonary function deterioration was more significant in the control group than in the intervention group. Preoperative tiotropium inhalation significantly improved pulmonary function and exercise tolerance in patients with COPD undergoing esophagectomy. The perioperative tiotropium did not reduce pneumonia after esophagectomy, but it may contribute to patient recovery by reducing postoperative pulmonary function deterioration.

Perioperative blood transfusions associated with reduced survival in gastroesophageal cancers – A Swedish population-based study

BackgroundBlood transfusion has been associated with decreased long-term survival in cancer patients, possibly due to various immunological factors. We aimed to evaluate if perioperative transfusions decrease survival in patients who undergo resection for esophageal or gastric cancer and to identify factors associated with such events. MethodsA population-based cohort study was conducted based on the Swedish National Registry for Esophageal and Gastric Cancer, which prospectively collects clinical data of patients with these tumors. Almost all patients (96 %) resected for esophageal or gastric cancer in Sweden between 2017 and 2022 were included. Survival data were acquired from the Swedish Cause of Death Registry. Multivariable Cox regression was used to calculate hazard ratios (HR) with 95 % confidence intervals (CI), adjusted for age, fitness, neoadjuvant therapy, surgical access, and pathological TNM stage. ResultsOf all 1365 patients, 227 (17 %) received perioperative transfusions. Transfusion was associated with an increased risk of all-cause mortality within 3 years of surgery (adjusted HR 1.50, 95 % CI 1.17–1.91). To exclude the influence of surgery-related postoperative complications, a sensitivity analysis was performed excluding patients who died within 30 days of resection and the negative impact of transfusions on 3-year mortality remained (adjusted HR 1.30, 95 % CI 1.01–1.68). Increasing age, open surgery, esophagectomy, perioperative bleeding, and nodal tumor involvement were all associated with an increased likelihood of receiving transfusions. ConclusionPerioperative blood transfusions might have a negative impact on 3-year survival in patients who undergo surgery for esophageal or gastric cancer.

The contemporary approach to chylothorax – Single-center experience with the proposal of a management algorithm

Objectives: Chylothorax is a relatively rare condition of lymphatic fluid accumulation in the thoracic cavity due to a leakage from the thoracic duct or its tributaries. Patients present with dyspnea, malnutrition, and immunosuppression. Treatment can be conservative or surgical, depending on etiology and clinical course. The optimal management algorithm for chylothorax is still controversial. Methods: This is a ten-year period retrospective study of all patients with chylothorax treated at our Department of Thoracic Surgery. Results: A total of 14 patients were identified for the study. Nine patients had chylothorax after lung or esophageal cancer surgery. Four patients had chylothorax in advanced lymphoma. One patient had chylothorax after blunt chest trauma. A conservative approach was initiated in most patients (92%), including pleural drainage, nil per mouth, total parenteral nutrition, and somatostatin 0.1 mg bid subcutaneously. Surgical treatment was indicated in patients with thoracic drain production &amp;gt;800 mL per day beyond the fifth day of treatment and those with blunt thoracic trauma. Two patients had thoracic duct ligation via right-sided thoracotomy, and five patients had video-assisted thoracoscopic thoracic duct ligation with the immediate arrest of chylous leakage. Conclusion: Chylothorax should be treated conservatively initially. Surgical treatment should not be delayed beyond the fifth day in case of failure. In our series of patients, a video-assisted thoracoscopic approach for thoracic duct ligation proved to be minimally invasive, highly efficient, and well tolerated. Therefore, it should be the preferable route of surgical treatment.

Thromboprophylaxis in oesophageal cancer patients—a study protocol for a randomised, controlled trial (TOP-RCT)

BackgroundThe purpose of the study is to examine if prolonged thromboprophylaxis decreases the risk of thrombosis after intended curative surgery for oesophageal cancer.Study results are expected to inform a guideline for thromboprophylaxis after oesophageal cancer surgery. The perspective is to reduce morbidity and mortality in this critically ill patient group.Thrombosis is the second-most common cause of cancer death after the cancer itself. The risk of thrombosis depends on the cancer type, and upper gastrointestinal cancers are considered high risk. This risk is further increased when patients undergo surgery. However, only few studies have investigated the peri- and postoperative coagulation profile in oesophageal cancer patients. Due to this lack of knowledge, prophylaxis is currently restricted to 5000 IU (international units) low-molecular weight heparin daily from surgery until discharge from hospital (approximately 10 days), whereas patients with gastric cancer receive 30 days of treatment.The present study examines whether a 30-day treatment is superior and safe, compared with the current standard treatment.MethodsThe study is a randomised controlled trial. Inclusion is ongoing, and we aim to include 100 patients. Blood samples are drawn before and after surgery, and the coagulation is extensively examined. The primary endpoint is the difference in plasma levels of prothrombin fragment 1 + 2 (F1 + 2) 30 days after surgery between the intervention and the standard group. Furthermore, patients are examined with ultrasound to screen for asymptomatic venous thrombotic events (VTE).Secondary endpoints are incidence of bleeding, symptomatic and asymptomatic VTE and mortality 30 days 1 one year after surgery.DiscussionThe study will provide valuable information on the perioperative coagulation profile and VTE risk of oesophageal cancer patients. The study seeks to aid in optimising the postoperative thromboprophylaxis, and the perspective is to reduce morbidity and mortality in this at-risk patient population.Trials registrationThe trial was prospectively registered at the EU Clinical Trials Register with ID 2021–001335-24 on 30 June 2021 and at ClinicalTrials.gov with study identifier NCT05067153.

331. CASE-MIX ADJUSTMENT IN BETWEEN-HOSPITAL COMPARISONS ON CLINICAL OUTCOMES IN ESOPHAGEAL AND GASTRIC CANCER SURGERY: A NATIONWIDE POPULATION-BASED COHORT STUDY

Abstract Background Clinical outcomes of esophageal and gastric cancer surgery are used for internal and external benchmarking in clinical auditing. For true hospital comparisons, proper case-mix adjustment is required. This study aimed to develop distinct models that allow for case-mix adjusted quality assessment of esophageal and gastric cancer surgery separately and assessed the impact on between-hospital comparisons. Methods This study included all patients undergoing esophagogastric cancer surgery in the Netherlands between 2017-2022 registered in the Dutch Upper Gastrointestinal Cancer Audit. We developed distinct case-mix adjustment models for ten quality indicators (QIs) using backward selection. Model performance of each individual model was evaluated with area-under-the-receiving-operator-curve (AUC) statistics, representing the impact of case-mix on the QI scores. The impact on between-hospital comparisons was quantified using unadjusted and adjusted O/E ratios. Results A total of 4,354 esophageal cancer and 2,109 gastric cancer patients were included. The most frequently selected case-mix variables in the models for all QIs for esophageal cancer surgery were ASA-score, salvage surgery, peripheral vascular disease/aortic aneurysm, chronic lung disease, and tumor histology, whereas for gastric cancer these were age, preoperative weight loss, tumor location, and clinical M stage. The case-mix adjustment models for esophageal and gastric cancer surgery showed low to moderate performance, with internally validated AUCs of 0.58-0.73 and 0.58-0.74, respectively. Case-mix adjustment had low impact on between-hospital comparisons. For both types of cancer, case-mix adjustment had most pronounced impact on between-hospital comparisons for QIs 30-day/in-hospital mortality and failure-to-rescue. Conclusion This study showed that correct quality assessment requires different case-mix models per quality indicator for clinical outcomes of esophageal and gastric cancer surgery. The case-mix models had low to moderate performance scores, suggesting that case-mix has limited impact in between-hospital comparisons of oesopagogastric cancer surgery.