Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial.

BACKGROUND & AIMS: Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. METHODS: We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. RESULTS: There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. CONCLUSIONS: In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR. (Clinicaltrials.gov, Number NCT03654209.).

Do patients actually understand? An evaluation of the informed consent process for endoscopic procedures in rural Uganda.

INTRODUCTION: Improving surgical access in low- and middle-income countries is vital for the 5 billion people who lack safe surgical care. Tailoring a culturally sensitive approach to consent is essential for patient comprehension and comfort, thereby alleviating the effects of resource constraints and advancing equitable care. This study examines the consenting process for endoscopy at Kyabirwa Surgical Center in Kyabirwa, Jinja, Uganda, to assess patients' knowledge and attitudes as a potential barrier to participating in endoscopic procedures. METHODS: All adult upper endoscopy (EGD) and colonoscopy patients were recruited to participate in a survey of their demographics, knowledge, and attitudes toward their procedure. All patients received a standard consultation explaining the procedure and its risks and benefits. RESULTS: 75 patients were included; median age was 54 years and 56% (n = 42) were women. 92% (n = 69) of patients had never had an endoscopy before and 73% (n = 55) of patients were scheduled for an EGD while the remaining 27% (n = 20) were scheduled for a colonoscopy. Most patients 80% (n = 60) had a basic understanding of what an endoscopy is and 87% (n = 65) its diagnostic purpose. Few patients 15% (n = 11) knew of the most common side effects or if they would have a surgical scar 27% (n = 20). Overall, 46.7% (n = 35) of patients were moderately or severely fearful of getting an endoscopy. Additionally, 45.3% (n = 34) of patients were moderately or severely fearful of receiving anesthesia during their endoscopic procedure. Despite this fear, most patients 85.3% (n = 64) stated that they understood the benefits of the procedure either very well or extremely well. CONCLUSIONS: Most patients understood the role that an endoscopic procedure plays in their care and its potential benefits. Despite this, many patients continued to have high levels of fear associated with both the endoscopic procedure and with receiving anesthesia during their procedure. Future patient education should focus on addressing patients' fears and the risks of undergoing an endoscopy, which may improve the utilization of surgical services.

Remote training and teleproctoring in gastrointestinal endoscopy for practicing surgeon in rural Uganda.

BACKGROUND: There is a significant, unmet need for endoscopy services in rural Uganda. With limited diagnostic and therapeutic interventions, patients in these communities often present with advanced disease. Practicing surgeons must continually adapt to new techniques to meet the needs of their patient populations. Here, we present a remotely proctored endoscopy training program for a surgeon practicing in an area devoid of endoscopic capabilities. METHODS: This was a retrospective case series conducted between February 2020 and December 2022 at Kyabirwa Surgical Center (KSC). After a 1-week in-person training camp, one surgeon performed endoscopy under guidance of a remote proctor. Patient data and outcomes were collected retrospectively. RESULTS: The previously endoscopic naïve practicing Ugandan surgeon was remotely proctored for 139 endoscopic cases and he subsequently independently performed 167 diagnostic colonoscopies and 425 upper endoscopies. Therapeutic endoscopy was conducted under remote guidance after proficiency in diagnostic endoscopy. A total of 43 therapeutic procedures were performed, including 29 esophageal stent placements, 5 variceal bandings, and 9 foreign body retrievals. All procedures were completed without complication. CONCLUSION: Our center developed a remotely proctored endoscopy program that allowed for training of practicing surgeons in an area lacking endoscopic services. Despite its limitations, remotely proctored endoscopy serves as a unique but highly valuable method of expanding access to endoscopy, particularly in areas that lack adequate training opportunities.

Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Chromoendoscopy Is More Effective Than Standard Colonoscopy in Detecting Dysplasia During Long-term Surveillance of Patients With Colitis.

BACKGROUND & AIMS: Patients with colitis have an increased risk of colorectal cancer, compared with persons without colitis. Many studies have shown chromoendoscopy (CE) to be superior to standard methods of detecting dysplasia in patients with colitis at index examination. We performed a prospective, longitudinal study to compare standard colonoscopy vs CE in detecting dysplasia in patients with inflammatory bowel diseases in a surveillance program. METHODS: We analyzed data from 68 patients (44 men, 24 women) diagnosed with ulcerative colitis (n = 55) or Crohn's disease (n = 13) at Mount Sinai Medical Center from September 2005 through October 2011. The patients were followed from June 2006 through October 2011 (median, 27.8 months); each patient was analyzed by random biopsy, targeted white light examination (WLE), and CE. Specimens were reviewed by a single blinded pathologist. The 3 methods were compared by using the generalized estimating equations method, and the odds ratios (ORs) for detection of dysplasia were calculated (primary outcome). Time to colectomy was analyzed by using the Cox model. RESULTS: In the 208 examinations conducted, 44 dysplastic lesions were identified in 24 patients; 6 were detected by random biopsy, 11 by WLE, and 27 by CE. Ten patients were referred for colectomy, and no carcinomas were found. At any time during the study period, CE (OR, 5.4; 95% confidence interval [CI], 2.9-9.9) and targeted WLE (OR, 2.3; 95% CI, 1.0-5.3) were more likely than random biopsy analysis to detect dysplasia. CE was superior to WLE (OR, 2.4; 95% CI, 1.4-4.0). Patients identified as positive for dysplasia were more likely to need colectomy (hazard ratio, 12.1; 95% CI, 3.2-46.2). CONCLUSIONS: In a prospective study of 68 patients with inflammatory bowel diseases, CE was superior to random biopsy or WLE analyses in detecting dysplasia in patients with colitis during an almost 28-month period. A negative result from CE examination was the best indicator of a dysplasia-free outcome, whereas a positive result was associated with earlier referral for colectomy.

Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths.

BACKGROUND: In the National Polyp Study (NPS), colorectal cancer was prevented by colonoscopic removal of adenomatous polyps. We evaluated the long-term effect of colonoscopic polypectomy in a study on mortality from colorectal cancer. METHODS: We included in this analysis all patients prospectively referred for initial colonoscopy (between 1980 and 1990) at NPS clinical centers who had polyps (adenomas and nonadenomas). The National Death Index was used to identify deaths and to determine the cause of death; follow-up time was as long as 23 years. Mortality from colorectal cancer among patients with adenomas removed was compared with the expected incidence-based mortality from colorectal cancer in the general population, as estimated from the Surveillance Epidemiology and End Results (SEER) Program, and with the observed mortality from colorectal cancer among patients with nonadenomatous polyps (internal control group). RESULTS: Among 2602 patients who had adenomas removed during participation in the study, after a median of 15.8 years, 1246 patients had died from any cause and 12 had died from colorectal cancer. Given an estimated 25.4 expected deaths from colorectal cancer in the general population, the standardized incidence-based mortality ratio was 0.47 (95% confidence interval [CI], 0.26 to 0.80) with colonoscopic polypectomy, suggesting a 53% reduction in mortality. Mortality from colorectal cancer was similar among patients with adenomas and those with nonadenomatous polyps during the first 10 years after polypectomy (relative risk, 1.2; 95% CI, 0.1 to 10.6). CONCLUSIONS: These findings support the hypothesis that colonoscopic removal of adenomatous polyps prevents death from colorectal cancer. (Funded by the National Cancer Institute and others.).

Standardized endoscopic reporting.

The need for standardized language is increasingly obvious, also within gastrointestinal endoscopy. A systematic approach to the description of endoscopic findings is vital for the development of a universal language, but systematic also means structured, and structure is inherently a challenge when presented as an alternative to the normal spoken word. The efforts leading to the "Minimal Standard Terminology" (MST) of gastrointestinal endoscopy offer a standardized model for description of endoscopic findings. With a combination of lesion descriptors and descriptor attributes, this system gives guidance to appropriate descriptions of lesions and also has a normative effect on endoscopists in training. The endoscopic report includes a number of items not related to findings per se, but to other aspects of the procedure, formal, technical, and medical. While the MST sought to formulate minimal lists for some of these aspects (e.g. indications), they are not all well suited for the inherent structure of the MST, and many are missing. Thus, the present paper offers a recommended standardization also of the administrative, technical, and other "peri-endoscopic" elements of the endoscopic report; important also are the numerous quality assurance initiatives presently emerging. Finally, the image documentation of endoscopic findings is becoming more obvious-and accessible. Thus, recommendations for normal procedures as well as for focal and diffuse pathology are presented. The recommendations are "minimal," meaning that expansions and subcategories will likely be needed in most centers. Still, with a stronger common grounds, communication within endoscopy will still benefit.

Ambulatory Surgery Center in Rural Uganda: A Novel Approach to Providing Surgical Care.

BACKGROUND: Despite evidence that ambulatory surgery is safe with faster recovery compared to in-patient hospitalization, surgeons in low- and middle-income countries like Uganda have been hesitant to embrace this practice. Kyabirwa Surgical Center (KSC) is the first freestanding ambulatory surgery center (ASC) in rural Uganda. We aim to report the impact of a rural ASC since its establishment, in alleviating surgically-treatable morbidity within its catchment area. METHODS: KSC is located in Jinja, Uganda. The center's electronic medical record was used to analyze the utilization of services, and the Uganda Bureau of Statistics was used to calculate KSC's catchment area. Effectiveness was calculated using disability-adjusted life years (DALYs) averted. RESULTS: Between July 2019 and December 2021, 7,391 patients (57.7% female, 42.3% male) visited KSC from a catchment area of 570,790 people. Of 1,355 procedures, 64.6% were general surgery, 21.3% endoscopy, 9.2% gynecological/genitourinary), 2.8% ENT, 1.5% colorectal, and 0.6% orthopedics. There were no postoperative hospital admissions for complications or mortalities. From the seven most common procedures with an associated disability weight, 2,193.16 total DALYs were averted. CONCLUSION: ASCs can be effective in addressing surgical care gaps in Uganda by increasing the yearly surgical capacity of the local catchment area and averting DALYs within the population.

Colon polypectomy: a review of routine and advanced techniques.

The value of performing comprehensive screening colonoscopy with complete colon polypectomy is widely accepted. Colon cancer is a significant cause of worldwide mortality and prospective studies have proven that colonoscopic polypectomy reduces both the incidence and mortality related to this disease. Over the past few decades the array of instruments and techniques have greatly expanded to assist with the safe endoscopic removal of colon polyps. This article will review the published literature regarding efficacy and safety of standard polypectomy techniques such as snare polypectomy, electrocautery, and endoscopic mucosal resection along with newer techniques such as endoscopic submucosal dissection and combined laparoscopic techniques.

Guidelines for designing a digestive disease endoscopy unit: report of the World Endoscopy Organization.

A dedicated digestive disease endoscopy unit is structurally and functionally differentiating rapidly as a result of increasing diagnostic and therapeutic possibilities in the last 10-20 years. Publications with practical details are scarce, imposing a challenge in the construction of such a unit. The lack of authoritative information about endoscopy unit design means that architects produce their own design with or without consulting endoscopists working in such a unit. A working group of the World Endoscopy Organization discussed and outlined a practical approach fordesign and construction of a modern endoscopy unit. Designing the layout is extremely important, necessitating thoughtful planning to provide comfort to the endoscopy staff and patients, and efficient data archiving and transmission during endoscopic services.

Routine and advanced polypectomy techniques.

The performance of colon polypectomy has proven to be one of the most impactful services provided by today's endoscopist. Advancements in instrumentation and endoscopic techniques have been studied intensely by endoscopists over the past decade in order to expand their extent of resection capabilities to large and complex polyps. Much of the research in the past year has focused on the safety and efficacy of performing endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and combined laparascopic-endoscopic resections (CLER). Experts have published case-series, multicenter studies, and even nationwide results on the use of these methods for complex polypectomy. Because of the novelty and increased risk of these procedures, recent research has also focused on the prevention, identification and management of complications related to polypectomy, particularly bleeding and perforation. This manuscript will review the recent literature addressing basic and advanced colon polypectomy techniques.

Computer-assisted brush-biopsy analysis for the detection of dysplasia in a high-risk Barrett's esophagus surveillance population.

BACKGROUND: Barrett's epithelial dysplasia, the direct precursor to esophageal adenocarcinoma, is often unapparent and frequently missed during surveillance of Barrett's esophagus with four-quadrant forceps biopsy protocol. AIM: To determine whether the detection of dysplasia is improved by adding computer-assisted brush biopsy (EndoCDx©) to four-quadrant biopsy protocol. METHODS: Patients with a history of Barrett's esophagus with dysplasia scheduled for endoscopic surveillance were recruited from four academic medical centers. Patients underwent brush biopsy followed by four-quadrant biopsy every 1-2 cm. The results from brush and forceps biopsy were reviewed independently by pathologists blinded to the other's results. RESULTS: Among 151 patients enrolled (124 men, 27 women; mean age: 65), 117 (77.5%) had forceps and brush-biopsy specimens adequate for interpretation. The mean number of forceps biopsies was 11.9 (median 10, range 2-40) and brush biopsies was 2.0 (median 2, range 1-4). The overall yield of forceps alone was 25.2% (n = 38). Brush biopsy added an additional 16 positive cases increasing the yield of dysplasia detection by 42% (95% CI: 20.7-72.7). The number needed to test (NNT) to detect one additional case of dysplasia was 9.4 (95% CI: 6.4-17.7). There were no significant differences in results among different centers, between standard versus jumbo forceps, or between forceps biopsies taken every 1 cm versus every 2 cm. CONCLUSIONS: These data suggest that computer-assisted brush biopsy is a useful adjunct to standard endoscopic surveillance regimens for the identification of dysplasia in Barrett's esophagus.

Remote training in flexible gastrointestinal endoscopy.

Video 1Remote training in flexible GI endoscopy.

A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos).

BACKGROUND: Colonoscopy may fail to detect neoplasia located on the proximal sides of haustral folds and flexures. The Third Eye Retroscope (TER) provides a simultaneous retrograde view that complements the forward view of a standard colonoscope. OBJECTIVE: To evaluate the added benefit for polyp detection during colonoscopy of a retrograde-viewing device. DESIGN: Open-label, prospective, multicenter study evaluating colonoscopy by using a TER in combination with a standard colonoscope. SETTING: Eight U.S. sites, including university medical centers, ambulatory surgery centers, a community hospital, and a physician's office. PATIENTS: A total of 249 patients (age range 55-80 years) presenting for screening or surveillance colonoscopy. INTERVENTIONS: After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. MAIN OUTCOME MEASUREMENTS: The number and sizes of lesions (adenomas and all polyps) detected with the standard colonoscope and the number and sizes of lesions found only because they were first detected with the TER. RESULTS: In the 249 subjects, 257 polyps (including 136 adenomas) were identified with the colonoscope alone. The TER allowed detection of 34 additional polyps (a 13.2% increase; P < .0001) including 15 additional adenomas (an 11.0% increase; P < .0001). For lesions 6 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 18.2% and 25.0%, respectively. For lesions 10 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 30.8% and 33.3%, respectively. In 28 (11.2%) individuals, at least 1 additional polyp was found with the TER. In 8 (3.2%) patients, the polyp detected with the TER was the only one found. Every polyp that was detected with the TER was subsequently located with the colonoscope and removed. For all polyps and for adenomas, the additional detection rates for the TER were 9.7%/4.1% in the left colon (the splenic flexure to the rectum) and 16.5%/14.9% in the right colon (the cecum to the transverse colon), respectively. LIMITATIONS: There was no randomization or comparison with a separate control group. CONCLUSIONS: A retrograde-viewing device revealed areas that were hidden from the forward-viewing colonoscope and allowed detection of 13.2% additional polyps, including 11.0% additional adenomas. Additional detection rates with the TER for adenomas 6 mm or larger and 10 mm or larger were 25.0% and 33.3%, respectively. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00657371.).