Society: ASGE

Background: Endoscopic defect closure have been applied to reduce the adverse events rate after colorectal endoscopic submucosa dissection (ESD). As for the suturing device, the closure has usually been performed using through-the-scope clips (TTSC). However, suturing of large defects is challenging because clips are usually small and insufficient for closing mucosal defects. In addition, closure of a large wound by simple clipping usually results in suturing only the mucosal layer, which could be unreliable. Suturing all layers of the colorectal wall, like surgical suturing, is important for achieving robust closure. Although closure with over-the-scope clips or over-the-scope sutures allows robust closure, even for large defects, these methods require expensive dedicated devices. In addition, delivery to the proximal colon is sometimes difficult and time-consuming. Therefore, a suturing method using only TTSC, which can perform robust closure even for large mucosal defects, is necessary. Endoscopic double-layered suturing was reported to be a method that involves suturing not only the mucosal layer, but also the submucosal layer. In this method, TTSCs are applied on the submucosal layer at the center of the ulcer to shrink the defect and suture the mucosa and submucosa together. We noticed that introducing reopenable clips enabled us to gently fold muscle layers as well as the submucosal layer. Making a few folded muscle layers allowed complete closure of even extremely large defects. This modified double layered suturing is like folding origami which is the Japanese traditional art of folding paper. We speculated that this method, origami method (OGM), achieved reliable closure of even large defects, like surgical suturing. This study aimed to evaluate the feasibility of OGM for colorectal post-ESD defects. Methods: This retrospective observational study was conducted at a tertiary care hospital. We reviewed the cases of OGM attempted after colorectal ESD at our institute between October 2021 and October 2022, and measured the clinical characteristics and outcomes of enrolled cases. Results: The OGM was attempted in 47 cases after colorectal ESD. Thirty-one cases (66%) were in the proximal colon; five (11%) in the distal colon; six (13%) in the upper rectum; and five (10%) in the lower rectum. The median resected specimen size was 38 mm, the largest being 85 mm. Complete closure was achieved in 44 cases (94%), including the largest case and all lower rectum cases. There were no perforations caused by clips during closure, and delayed perforation and bleeding were not observed. Conclusions: This new suturing method, like surgical all layer suturing, is feasible and recommended. The OGM could achieve reliable closure of large defects in any location, including the proximal colon and thick-walled lower rectum, using only TTSC.

<b>Modified double layered suturing, origami method (OGM)</b>

Modified double layered suturing, origami method (OGM)

Introduction:
The Endoscopic HeliX Tacking System (Apollo Endosurgery, Inc.) is a through-the-scope (TTS) suture-based device that has been gaining popularity in defect closure due to the ease of use and ability to close larger and irregular mucosal defects. The barbs are attached to a polypropylene suture and are able to be implanted into the submucosal/intramuscular space to allow for soft tissue approximation. In theory, these tacks were designed to not have full thickness penetration at any point of the gastrointestinal (GI) tract. We present the first reported case of a closed loop small bowel obstruction due to unintentional full thickness insertion of the X-Tack device during mucosal closure after large colon polyp resection.

Case:
A 65-year-old man with no significant medical history presented as a referral for consideration of a 2.5cm cecal sessile polyp removal. The subtle lesion was subsequently found on the inferior aspect of the appendiceal orifice. A lifting agent was applied, and an adequate cushion was created prior to resection. The polyp was removed in a piecemeal fashion with a mixture of hot snare and cold snare techniques. The edges were treated with argon plasma coagulation. The resection site was closed using the Endoscopic HeliX Tacking System with four tacks and a cinch and no extra tools were utilized. Histology returned as a sessile serrated polyp. The patient recovered well form the procedure with no immediate complications.

One month later, he presented to with severe, diffuse abdominal pain and abdominal distension. CT abdomen and pelvis revealed a closed loop distal small bowel obstruction. As a result, he was urgently taken to the operating room for laparoscopy. During laparoscopic evaluation, the barbs of the X-tack had full thickness penetration into the mesentery which led to the peritoneum being shifted down creating a hernia space that caused torsion and subsequent obstruction of the nearby small intestine, which had migrated. A successful small bowel resection and side to side functional end to end enteroenterostomy was performed and the patient did well afterwards.

Discussion:
In porcine models, X-tacks were utilized for closure of gastric and rectosigmoid perforations with high success and no reports of full thickness penetration of the barbs. However, there is limited data within the thinner walled areas of the GI tract. We present the first known reported case of a full thickness complication of the X-tack device with subsequent closed loop small bowel obstruction. While the X-tack device has expanded our capabilities for closing large mucosal defects, full thickness insertion of the device is possible in thin-walled areas of the GI tract, and this should be taken into consideration when choosing mucosal closure options.

Full thickness X-tack into the mesentery

Full thickness X-tack into the mesentery

Closed loop small bowel obstruction related to full thickness X-tack

Closed loop small bowel obstruction related to full thickness X-tack

Background: Iatrogenic perforation is the most feared adverse event associated with endoscopy. American Society for Gastrointestinal Endoscopy (ASGE) and European Society of Gastroenterology Endoscopy (ESGE) guidelines recommend endoscopic closure as the first-line treatment strategy. Historically, this has been achieved using through-the-scope clips (TTSC). Given the emergence of alternative endoscopic closure techniques including over-the- scope clips (OTSC) and endoscopic suturing, we sought to provide an updated review of the literature.
Purpose: To review endoscopic closure techniques following iatrogenic perforation during screening or therapeutic endoscopic procedures.
Methods: Based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Guidelines, an electronic search of MEDLINE and EMBASE from 06/01/1946 – 10/10/2022 was performed. Inclusion criteria was limited to English full-text original citations, with case reports, and cohorts with < 3 patients excluded. Our primary objective was to assess complete defect closure after attempted endoscopic treatment. Outcomes were stratified by modality (TTSC, OTSC, endoscopic suturing) and chronologically based on a previous high level systematic review.
Results: A total of 2549 citations were identified in our electronic search, of which 34 were included representing 830 perforations. Overall, successful endoscopic closure was achieved in 763 cases (91.9%). When stratified by endoscopic closure techniques, range estimates for successful endoscopic closure was 71% – 100%, 57% - 100%, and 100% for TTSC, OTSC and endoscopic suturing respectively. When stratifying chronologically, an improvement in TTSC closure was identified.
Conclusion: Endoscopic defect closure, including TTSC, OTSC and endoscopic suturing, are effective in the management of iatrogenic perforations with increasing TTSC performance over time. It remains the primary treatment strategy for iatrogenic perforation.

Background and Aims: Nearly all routine endoscopy procedures are performed using moderate sedation (MS) or monitored anesthesia care (MAC). In this article, we describe how we improved decision-making and decreased practitioners’ cognitive burden for choosing between MAC and MS by utilizing patient data in an intelligent application within the electronic health record (EHR).

Methods: In our practice, we choose between MS or MAC for routine gastrointestinal (GI) procedures according to written anesthesia use guidelines and practitioner preferences. To expedite our decision-making for MS vs MAC, we developed an Excel-based tool from patient demographic characteristics, comorbid conditions, and medication use extracted from the EHR. The data points from Excel were then implemented in the intelligent application in the EHR to predict the type of sedation for GI procedures.

Results: During the study, MS was used for 1,172 procedures. In 3 of these procedures, the patients received fentanyl dosages over 200 mcg. Only one procedure was aborted because of ineffective sedation, which was similar to the number of failures before use of the application.Before use of the new application, nurses spent an average of 4 minutes and gastroenterology practitioners spent 5 minutes reviewing the EHR to determine the appropriate sedation (MS or MAC). After the application was implemented, the use of MS substantially increased from 58% of total cases to 72% of total cases. The rate of adverse events for MS (0.5%) vs MAC (0.6%) was comparable and low overall.

Conclusions: The EHR-based intelligent application, which automates and standardizes determination of sedation type, is a highly beneficial tool that
eliminates subjectivity in decision-making, thus allowing for appropriate use of MAC. Complication rates and sedation failure did not increase with use of
the application. With the increase in use of MS over MAC, health care costs for the more expensive MAC sedation should also decrease.

Adverse events

Efficacy and safety of NAAP for gastrointestinal endoscopy have been widely documented although there is not information about the outcomes of ERCP itself when the endoscopist supervises the sedation.

Objective:
To determine the equivalence of bile duct canulation rate (BDCR) and management of pathology (MP), including clearance of common bile duct (cCBD) and stent placement for biliary obstruction (spBO), in ERCP performed with NAAP and performed with monitored anesthesia care (MAC).

Method:
Single blind non-randomized controlled equivalence trial that enrolled adult patients admitted for ERCP in two centers. Intervention: patients were blindly assigned to undergo either ERCP with NAAP or MAC according to the day of admission (Monday: NAAP, Wednesday and Thursday: MAC). NAAP was carried out by an expert team directed by an endoscopist who in turn performed ERCP. Main outcome measure: BDCR and MP (cCBD and spBO) in ERCP performed with NAAP.

Results:
We included 938 patients, 352 in NAAP and 586 in MAC. Age: 72.59 ±0.53 years-old, 50.7% women. The ERCP indication was proper in 94.6% and ERCP complexity, 3-4 in 51.5%. BDCR: 94.7%, MP: 92.8% - cCBD: 91.3% and spBO: 92.8%. Complication rate (CR): 9.2%, postERCP pancreatitis (PEP): 2.5% and deaths related to ERCP: 0.3% .
Analysis by per protocol showed a BDCR in ERCP performed with NAAP =93.8% compared with 95.4% in those performed with MAC, difference (ΔBDCR) =1.6; 95%CI ΔBDCR: -0.05 – 0.01. MP in NAAP =92.6% vs MP in MAC =93%, difference (ΔMP): 0.4; 95%CI ΔMP: -0.04 – 0.03. There were no differences neither in global CR nor in PEP rate between NAAP and MAC.

Conclusions:
Bile duct cannulation rate and management of pathology in ERCP performed with non-anesthesiologist administered propofol are equivalent to those performed with monitored anesthesia care. Similarly, there is no difference in the complication rate.

Background: Current USPSTF guidelines only recommend selective screening for colorectal cancer in adults aged 76 to 85 years, taking into consideration the patient’s overall health, prior screening history, and personal preferences. Limited evidence suggests that the potential harms from colonoscopy increase with patient age. A modified five item frailty index (mFI-5) has been shown to be effective at predicting adverse surgical outcomes. Currently, it is unknown if the mFI-5 frailty index can be used to predict adverse events during and following colonoscopy in the elderly population.

Methods: In this single tertiary care medical center retrospective study, the medical record was reviewed for patients age 75 and older undergoing outpatient colonoscopy for all indications from 11/1/2017 to 10/7/2022. Records were further reviewed for ICD-10 codes associated with colorectal cancer screening and adenoma surveillance, demographic data, and comorbidities needed to calculate the mFI-5 [medically treated hypertension, diabetes, heart failure, COPD, and non-independent functional status]. Functional status was electronically extracted using natural language processing and SNOMED-CT concepts, and manually validated through random sampling. The primary outcome was survival during follow up interval. Additional outcomes included 30-day hospitalization and 30-day mortality.

Results: A total of 4110 unique patient encounters were identified for analysis. Patients had a median age of 77 years [IQR 76-80], BMI 27 [IQR 24-31]; 52% female. A total of 42 short-term events (36 hospitalizations, 6 deaths) and 207 deaths occurred during the study period with a median follow up of 1.44 years [IQR 0.50-3.03]. In multivariate analysis, controlling for age and BMI, frailty was associated with increased long-term all-cause mortality (HR 1.83, 1.58-2.11, p<0.01). In multivariate analyses controlling for age, frailty was associated with increased 30-day hospitalization (OR 1.69, 1.21-2.36, p<0.01). In univariate analysis, frailty was associated with increased 30-day mortality (OR 3.42, 1.65-6.98, p<0.01). In subgroup analysis of screening and surveillance cases, we found similar results regarding survival during follow-up (Table 1), however no short-term adverse events occurred. Ordinal increase in mFi-5 was shown to have reduced survival during the follow up interval (Figure 1).

Conclusion: Frailty, as measured by the mFI-5, was a significant predictor of mortality in elderly patients undergoing outpatient colonoscopy. Short-term adverse events were likewise predicted by the mFI-5 overall but not in the subgroup of patients undergoing screening/surveillance. While colonoscopy remains relatively safe in this population, patients with higher frailty may incur an increased rate of adverse events and benefit less from ongoing surveillance due to decreased life expectancy.

Table 1: Hazard and odds ratios for mortality during follow up period, 30-day hospitalization, and 30-day mortality.

Table 1: Hazard and odds ratios for mortality during follow up period, 30-day hospitalization, and 30-day mortality.

Figure 1: Kaplan-Meier plot of survival during follow up period.

Figure 1: Kaplan-Meier plot of survival during follow up period.

John Vargo

Cleveland Clinic

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