Endoscopic Adverse Events Research Articles

Adverse events after colonoscopy in a randomised colorectal cancer screening trial

ObjectiveColonoscopy-related adverse events increase the burden of colorectal cancer (CRC) screening. This cross-sectional study evaluates adverse events during and after colonoscopy in a large, randomised CRC screening trial in Norway...

Professionalism in the Management Endoscopic Adverse Events - Consensus Document from the American College of Gastroenterology Professionalism Committee.

Professionalism in the Management Endoscopic Adverse Events - Consensus Document from the American College of Gastroenterology Professionalism Committee.

The Awareness and Experience About Endoscopic Adverse Events Among South Korean Endoscopists.

The number of endoscopic procedures and related adverse events is increasing. We investigated South Korean endoscopists' awareness and experience of endoscopic adverse events. We used Google Forms to conduct an online questionnaire survey among South Korean endoscopists from December 11 to 29, 2020. The survey comprised 30 questions developed by members of the Quality Management Committee of the Korean Society of Gastrointestinal Endoscopy. In total, 475 endoscopists participated in the survey. Of these, 454 (95.6%) were board-certified gastroenterologists and 255 (53.7%) had >10 years of endoscopy experience. Most participants had experienced serious adverse events requiring hospitalization (80.4%, 382/475); however, only 100 (21.1%) were aware of programs for the prevention and management of adverse endoscopic events in their affiliated endoscopy centers. Most participants (98.5%, 468/475) agreed with the need for education on medical accidents for healthcare workers. Responses were inconsistent regarding the definition of adverse events formulated by the 2010 American Society for Gastrointestinal Endoscopy Workshop. Most participants were not aware of the minimal standard terminology (76.6%, 364/475) and had not used it when writing endoscopy reports (88.8%, 422/475). Responses were inconsistent regarding which events to record in endoscopy records. Further discussion on the nationwide adverse-event reporting system and education program for adverse events related to endoscopy is needed to ensure the safety of patients and endoscopists.

Endoscopic injection sclerotherapy for treating recurrent bleeding of small bowel angioectasias

BackgroundThere is still no consensus on the preferred endoscopic therapy for small bowel angioectasias (SBAs). The aim of this study was to evaluate effectiveness and safety of endoscopic injection sclerotherapy (EIS) for treating recurrent bleeding of SBAs.MethodsSixty-six adult patients diagnosed with SBAs by capsule endoscopy (CE) or double-balloon enterscopy (DBE) examinations were enrolled in this retrospective study from September 2013 to September 2021. The patients were divided into an EIS group (35 cases) and a control group (31 cases) according to whether they underwent EIS treatment. Clinical characteristics, medical histories, lesion characteristics, main laboratory indicators, treatments, and outcomes were collected. The rates of re-bleeding, re-admission, and red blood cell (RBC) transfusion were compared between different groups after discharge. The rates of hospitalization and RBC transfusion were compared between before admission and after discharge in both groups. Odds ratios (ORs) and 95% confidence intervals (CIs) were used in the multivariate logistic regression analysis to assess relative factors for re-bleeding.ResultsAll the rates of re-bleeding, re-admission and RBC transfusion after discharge in the EIS group were significantly lower than those in the control group (all P < 0.05). The rates of hospitalization and RBC transfusion after discharge were significantly lower than those before admission in the EIS group (both P < 0.05), while those did not reach significant differences in the control group (both P > 0.05). Multivariate logistic regression analysis showed that RBC transfusion before admission (OR, 5.655; 95% CI, 1.007–31.758, P = 0.049) and multiple lesions (≥ 3) (OR, 17.672; 95% CI, 2.246–139.060, P = 0.006) were significant risk factors of re-bleeding, while EIS treatment (OR, 0.037; 95% CI, 0.005–0.260, P < 0.001) was a significant protective factor. No endoscopic adverse events were observed during hospitalization and none of the enrolled patients died within 12 months after discharge.ConclusionEIS treatment had good effectiveness and safety for treating recurrent bleeding of SBAs, which could be considered as one of the first-line endoscopic treatment options for SBAs.

Successful Design and Implementation of a POEM Program for Achalasia in an Integrated Healthcare System.

Per Oral Endoscopic Myotomy (POEM) is a minimally invasive treatment for achalasia with results comparable to laparoscopic Heller myotomy (LHM). Studies have described the development of proficiency for endoscopists learning to perform POEM, and societies have defined educational and technical objectives for advanced endoscopy fellows in training. However, there is limited guidance on the organizational strategy and educational plan necessary to develop an achalasia service with POEM expertise. We aim to outline the steps for design and implementation of a successful POEM program. We reported our experience developing a multi-disciplinary clinical program for POEM and the steps taken to achieve procedural proficiency. We also reported our technical success (successful tunneling into the gastric cardia and myotomy of LES muscle fibers) and clinical success (post-procedure Eckardt score ≤ 3) at 3-6months and 12months post-procedure. Adverse events were classified per the ASGE lexicon for endoscopic adverse events. After creating a multi-disciplinary clinical program for achalasia and completing procedural proficiency for POEM, our technical success rate was 100% and clinical success rate 90% for the first 41 patients. One adverse event (2.4%) occurred, moderate in severity per the American Society of Gastrointestinal Endoscopy (ASGE) lexicon for adverse endoscopic events. In this study, we outlined the steps involved to establish a POEM service in a large integrated healthcare system. Prior competency in interventional endoscopy, procedural training models, POEM observation and education, proctorship, and interdisciplinary patient care are recommended.

Outpatient flexible endoscopic diverticulotomy for the management of Zenker’s diverticulum: a retrospective analysis of a large single-center cohort

Flexible endoscopic Zenker's diverticulotomy (EZD) is well established as a safe and effective technique. Because of rare but concerning adverse events, most centers admit patients for observation and barium swallow study. Our center routinely performs EZD as a day procedure, discharging appropriate patients on the same day after clinical review. This study evaluates outcomes of this cohort compared with previously published studies where patients are admitted for observation. A retrospective analysis was performed of EZD procedures done at our center using a flexible endoscope and, in most cases, a diverticulotomy overtube with patients under moderate sedation or general anesthesia. Patients were observed for 2 hours and discharged if no clinical concerns were found. Patient comorbidities, American Society of Anesthesiologists physical status, and endoscopic adverse events were recorded against the American Society for Gastrointestinal Endoscopy severity grading system. Two hundred forty EZD procedures were performed between January 2015 and February 2021. Eleven (4.6%) intraprocedural adverse events occurred: 4 perforations, 4 bleeds, and 1 each postprocedural pain, delirium, and vomiting, respectively. All were recognized within the 2-hour observation period and were managed conservatively, except 1 patient who required surgery. Six patients (2.5%) presented with delayed adverse events: 2 bleeds, 2 perforations, and 2 postprocedural pain. All patients recovered uneventfully with supportive care. All significant adverse events requiring endoscopic or surgical intervention were identified before discharge. Delayed adverse events occurred in 2.5% of cases, all of which were managed supportively. Our data are comparable with published cohorts of admitted patients, demonstrating that appropriately selected patients may be managed as outpatients while maintaining similar safety outcomes.

Adverse Event Fatalities Related to GI Endoscopy.

Death after endoscopy is rare, under-reported, and has variable causes. This study aimed to evaluate the incidence and causes of fatal endoscopic adverse events (AEs) across two academic medical centers and to identify patient-, procedure-, and sedation-related risk factors. This is a retrospective cohort study of fatal adverse events causally related to endoscopy at Denver Health Medical Center and the University of Colorado Hospital from 2011 to 2020. Fatal AEs were retrieved from the physician-reported database. Electronic medical records were then reviewed to determine medical history, procedure details, subsequent treatments, and time and cause of death. From January 2011 to January 2020, 146,010 GI endoscopy procedures were performed. Median patient age was 70 [51-78] and 57% were male. Thirty-one deaths were identified, 28 of which were attributed to endoscopy, yielding a procedure-related fatality rate of 0.018%. Procedures included 11 EGDs, one colonoscopy, two flexible sigmoidoscopies, six ERCPs, seven upper EUS, and one PEG-J tube placement. Specific causes of death included aspiration in four patients (14%); cardiac arrest or myocardial infarction in seven patients (25%); perforation in nine patients (32%); bleeding in four patients (14%); cholangitis or sepsis without perforation in three patients (11%); and acute pancreatitis in one patient (3.6%). Fatal endoscopic AEs were rare but tended to occur in older patients with major comorbidities. Most deaths occurred from aspiration pneumonia, cardiac arrest, or perforation-related sepsis within 1week of the procedure.

Endoscopic Negative Pressure Therapy (ENPT) Is Superior to Stent Therapy for Staple Line Leak After Sleeve Gastrectomy: a Single-Center Cohort Study

PurposeStaple line leak (SLL) is a serious complication after sleeve gastrectomy (SG). Common endoscopic treatment options include self-expandable metallic stent (SEMS), endoscopic internal drainage (EID), and endoscopic closure. The endoscopic negative pressure therapy (ENPT) is a promising treatment option combining temporary sealing of the defect with drainage of the inflammatory bed. In this study, we compare the outcome of ENPT and SEMS for the treatment of SLL following SG.Materials and MethodsA retrospective cohort of 27 patients (21 females) treated at a single center for SLL after SG was included. ENPT was primary therapy for 14 patients and compared with 13 patients treated primarily using SEMS.ResultsENPT was associated with a significant reduction of hospital stay (19 ± 15.1 vs. 56.69 ± 47.21 days, p = 0.027), reduced duration of endoscopic treatment (9.8 ± 8.6 vs. 44.92 ± 60.98 days, p = 0.009), and shorter transabdominal drain dwell time (15 (5–96) vs. 45 (12–162) days, p = 0.014) when compared to SEMS. Whereas endoscopic management was successful in 12/14 (85.7%) of patients from the ENPT group, SEMS was successful in only 5/13 (38.5%) of patients (p = 0.015). Furthermore, ENPT was associated with a significant reduction of endoscopic adverse events compared with SEMS (14.3% vs. 76.92% p = 0.001).ConclusionCompared with SEMS, ENPT is effective and safe in treating SLL after SG providing higher success rates, shorter treatment duration, and lower adverse events rates.

Multicenter cohort study of patients with buried bumper syndrome treated endoscopically with a novel, dedicated device

Buried bumper syndrome (BBS) is a rare adverse event of percutaneous endoscopic gastrostomy (PEG) placement in which the internal bumper migrates through the stomal tract to become embedded within the gastric wall. Excessive tension between the internal and external bumpers, causing ischemic necrosis of the gastric wall, is believed to be the main etiologic factor. Several techniques for endoscopic management of BBS have been described using off-label devices. The Flamingo set is a novel, sphincterotome-like device specifically designed for BBS management. We aimed to evaluate the effectiveness of the Flamingo device in a large, homogeneous cohort of patients with BBS. A guidewire was inserted through the external access of the PEG tube into the gastric lumen. The Flamingo device was then introduced into the stomach over the guidewire. This dedicated tool can be flexed by 180 degrees, exposing a sphincterotome-like cutting wire, which is used to incise the overgrown tissue until the PEG bumper is exposed. A retrospective, international, multicenter cohort study was conducted on 54 patients between December 2016 and February2019. The buried bumper was successfully removed in 53 of 55 procedures (96.4%). The median time for the endoscopic removal of the buried bumper was 22 minutes (range, 5-60). Periprocedural endoscopic adverse events occurred in 7 procedures (12.7%) and were successfully managed endoscopically. A median follow-up of 150 days (range, 33-593) was performed in 29 patients (52.7%), during which no significant adverse events occurred. Through our experience, we found this dedicated novel device to be safe, quick, and effective for minimally invasive, endoscopic management of BBS.

Impact of adenoma detection rate on detection of advanced adenomas and endoscopic adverse events in a study of over 200,000 screening colonoscopies

Adenoma detection rate (ADR) is the best established quality parameter for screening colonoscopy. Guidelines recommend a target ADR >25% because previous studies have shown that patients of endoscopists with higher ADRs have a lower risk of postcolonoscopy interval cancers. However, studies have shown that improvement in ADR mainly results in increased detection of clinically irrelevant nonadvanced adenomas (NAAs). The impactof ADR on the detection of advanced adenomas (AAs) as well as adverse event rates has yet to be determined. A total of 218,193 screening colonoscopies performed between 2007 and 2010 by 262 endoscopists within the Austrian quality assurance program were analyzed. We divided endoscopists into quintiles based on ADRs and calculated mean advanced ADRs (AADRs), NAA detection rates (NAADRs), and adverse event rates for each quintile. Spearman rank-order was used to calculate overall correlations between ADRs and AADRs as well as adverse event rates. Endoscopists with an ADR<25% were compared with those with an ADR >25%. Fifty-one percent of patients were women. Mean ADR was 23.03% (95% confidence interval [CI], 21.93-24.13), AADRs 7.72% (95% CI, 7.19-8.25), and NAADRs 15.31% (95% CI, 14.36-16.27). Overall, there was a significant correlation between ADR and AADR (rho= .51; P< .001). When ADR was divided into quintiles, mean AADR increased with increasing ADR. Even in the highest ADR group (ADR, 31.36%-52.27%) there was a further increase in AADR with a mean of 10.75% (95% CI, 9.31-12.19). Importantly, NAADRs increased continuously with improvement in ADRs but never dissociated from a simultaneous improvement in AADRs. However, there was also a significant correlation of ADRs and endoscopic adverse events (rho= .26, P< .001), even if the perforation rate of .028% (95% CI, .004-.052) in the highest ADR group still remained within the accepted limits based on guidelines. Increasing ADR is associated with improved detection of AAs and therefore is likely to prevent more cases of colorectal cancer. However, higher ADR was also associated with a higher rate of adverse events, although the adverse event rate was low.

Adverse events of upper GI endoscopy

Adverse events of upper GI endoscopy

Su1350 Quality Endoscopy: Tracking Endoscopic Adverse Events Using an Electronic Medical Record System Is Superior to a Voluntary Reporting System

Endoscopy units traditionally track adverse events (AEs) and complications through reliance on self-reporting and close patient follow-up. These methods are subject to limitations that result in the under reporting of procedure-related AE. Our institution currently uses a voluntary electronic incident reporting system to track AEs. In addition, the GI division sends a weekly notice requesting AE reporting from on-service faculty, fellows and staff. Both tracking systems have a low reported rate of incidents involving high-risk procedures.

913 The ASA Classification: Does It Predict Adverse Events in Endoscopic Procedures?

The American Society of Anesthesiologists' (ASA) physical status classification has been used for over 50 years by anesthesiologists and surgeons as a predictor of peri-operative morbidity and mortality. The ability of ASA class to predict peri-endoscopy adverse events has not been studied. We hypothesize that increasing ASA class is associated with higher rates of peri-procedural adverse events in endoscopic procedures. Our aim was to describe the prevalence of immediate endoscopic adverse events stratified by ASA class and endoscopic procedure type.

Endoscopic complications—avoidance and management

The frequency of endoscopic complications is likely to rise owing to the increased number of indications for therapeutic procedures and also to the increased complexity of endoscopic techniques. Informed patient consent should be obtained as part of the procedure. Prevention of endoscopic adverse events is based on knowledge of the relevant risk factors and their mechanisms of occurrence. Thus, suitable training of future gastroenterologists and endoscopists is required for these complex procedures. When facing a complication, appropriate management is generally provided by an early diagnosis followed by prompt therapeutic care tailored to the situation. The most common complications of diagnostic and therapeutic upper gastrointestinal endoscopy, retrograde cholangiopancreatography, small bowel endoscopy and colonoscopy are reviewed here. Different modalities of medical, endoscopic or surgical management are also considered.

Advanced endoscopy procedures in private practice: is the juice worth the squeeze?

Advanced endoscopy procedures in private practice: is the juice worth the squeeze?

Variation in Care for Children With Esophageal Varices: A Study of Physicians', Patients', and Families' Approaches and Attitudes

Inadequate evidence to guide the management of children with esophageal varices may lead to variation in care and the provision of poor-quality care to some children. The aims of the study were to describe approaches taken by pediatric gastroenterologists for the management of esophageal varices in children, and to determine the attitudes of children, parents, and physicians toward screening endoscopy for identification of varices. Canadian pediatric gastroenterologists and hepatologists were questioned about their approaches to screening for esophageal varices and therapy to prevent or treat variceal hemorrhage. Consecutive children with portal hypertension and their parents were surveyed about attitudes to screening endoscopy. Forty-seven of 72 (65%) physicians responded. Seventy percent of respondents screen for esophageal varices in selected children, most using endoscopy (77%). Fifty-eight percent of respondents who screen for varices would provide primary prophylactic treatment. Most would treat an acute variceal bleed with antibiotics, acid suppression, octreotide, and endoscopy within 24 hours (76%) and then secondary prophylaxis with endoscopic variceal ligation (96%) or β-blockers (28%). Among 29 families surveyed, 63% of parents and 50% of patients would agree to screening endoscopy to understand their risk of variceal bleeding and 67% if prophylactic therapy were available. Families were more concerned about the risk of endoscopic adverse events than were gastroenterologists. Pediatric gastroenterologists vary in the care they provide for children at risk for esophageal varices and their attitudes toward the role of screening endoscopy differ from that of their patients. Further evidence is required to support practice guidelines that may reduce variation in care and thus improve its quality.

Identifying and reporting risk factors for adverse events in endoscopy. Part II: noncardiopulmonary events

The risks of endoscopy procedures are likely affected by the competence of the endoscopist and the team (nursing, anesthesia, and technicians), the details of the specific procedure being performed, and the patient's anatomy, demographics, and health status. In 2008, the American Society for Gastrointestinal Endoscopy (ASGE) convened a workshop to recommend a lexicon to define and describe the adverse events (AEs) (previously commonly referred to as complications) that can result from endoscopy procedures. 1 Cotton P.B. Eisen G.M. Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010; 71: 446-454 Abstract Full Text Full Text PDF PubMed Scopus (1128) Google Scholar One additional goal of this workshop was to standardize the reporting of factors that may predict AEs, in clinical practice and in research. This list of such factors might enable the creation of risk strata (allowing comparison of AE rates by risk groups). In addition, AE rates among different groups of endoscopists and different groups of patients might be more appropriately compared by strata. Last, prospective risk assessment might enhance the quality of informed consent and facilitate decisions regarding procedural appropriateness.

A lexicon for endoscopic adverse events: report of an ASGE workshop

A lexicon for endoscopic adverse events: report of an ASGE workshop