P0559 - Safety and Efficacy of Over-The-Scope Clip Systems in Patients Undergoing Gastrointestinal Endoscopy with Moderate Sedation: A Preliminary Analysis

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Willie M. Johnson, Jr., MD

University of Minnesota
Roseville, Minnesota

Mohamed Abdallah, MD¹, Anders Westanmo, PharmD², Susan Lou, MD³, Brian J. Hanson, MD², Andrew Reinink, MD³, Willie M. Johnson, MD⁴, Mohammad Bilal, MD²
¹University of Minnesota Medical Center, Minneapolis, MN; ²Minneapolis VA Medical Center, Minneapolis, MN; ³Minneapolis Veterans Affair Health Care System, Minneapolis, MN; ⁴University of Minnesota, Roseville, MN

Introduction: Over-the-scope-clip (OTSC) systems are increasingly used to manage gastrointestinal bleeding (GIB), perforations, fistulae, and anastomotic leaks. In the United States, most cases are performed with anesthesia assistance using general or monitored anesthesia care (MAC). Data is limited regarding the safety and efficacy of these systems during gastrointestinal (GI) endoscopic procedures under moderate sedation. This study aims to evaluate the safety and efficacy of OTSC systems use in gastrointestinal (GI) endoscopic procedures performed under moderate sedation.

Methods: This study is a single center, retrospective analysis of consecutive patients between 2018 and 2021 who underwent GI endoscopic procedures for GIB and fistula closure utilizing OTSC systems. Only procedures done under moderate sedation (midazolam and/or fentanyl) were included. Patient and procedural characteristics were noted. Primary outcomes were technical success and adverse events. Secondary outcomes were clinical success and requirement of a salvage procedure [surgery or interventional radiology (IR)] intervention.

Results: A total of 15 patients were included. Upper endoscopy was performed in 11, while lower endoscopy was performed in 4 (Table 1). Procedure indications were GIB and fistulae closures. Technical success was 100%. There was only one minor adverse event; minor and self-limited oropharyngeal bleed resulting from insertion of a clip. All patients tolerated moderate sedation well with mean fentanyl and midazolam doses of 109 mcg and 4.6 mg, respectively. Mean procedural duration was 29.8 minutes. Hemostasis was achieved in all cases of GIB except one requiring subsequent IR embolization for hemostasis. All cases for fistulae closure were successful. Therefore, clinical success was achieved in 14 cases (93.3%). There were no cases of mortality.

Discussion: Our study demonstrates that OTSC systems can be safely and effectively used in patients undergoing GI endoscopy under moderate sedation. Our preliminary analysis provides encouraging information for endoscopists in the United States who perform majority of their endoscopy cases with moderate sedation, and for practices where anesthesia use is limited due to resource constraints.

Patient Number	Age of Patient, yr	Gender	Clinical Condition	Comorbidities	Anticoagulation/Antiplatelet use
1	47	Male	Colonic polyp bleed	HTN, CAD, CHF, OSA, VALVULAR DISEASE	Yes
2	56	Male	Colonic polyp bleed with colonic mass	NONE	No
3	61	Male	Gastric fistula	NONE	No
4	62	Female	Gastric fistula	NONE	Yes
5	67	Male	Surgical site bleed in stomach	HTN, DM, CAD	Yes
6	68	Male	Colonic polyp bleed with colonic mass	DM	Yes
7	68	Male	Gastric polyp bleed	HTN	No
8	69	Male	Duodenal ulcer bleed	HTN, DM, CAD, CKD/ESRD, OBESITY	Yes
9	71	Male	Gastric ulcer bleed	HTN, DM, CAD, OBESITY	No
10	73	Male	Gastric fistula	HTN, OSA	No
11	78	Male	Duodenal ulcer bleed	HTN, DM, CAD, CKD/ESRD, CHF, VALVULAR DISEASE	Yes
12	86	Male	Duodenal ulcer bleed	HTN, CAD, VALVULAR DISEASE	Yes
13	88	Male	Gastric ulcer bleed	HTN, DM, CKD/ESRD, CHF, OBESITY	Yes
14	88	Male	Gastric ulcer bleed	HTN, CAD, CHF, COPD, VALVULAR DISEASE	No
15	90	Male	Gastric ulcer bleed	HTN, VALVULAR DISEASE	No

Table: Table 1: Patient demographic and clinical information of OTSC Application

Abbreviations: HTN: Hypertension, CAD: Coronary Artery Disease, CHF: Congestive Heart Failure, OSA: Obstructive Sleep Apnea, DM: Diabetes Mellitus, CKD/ESRD: Chronic Kidney Disease/End Stage Renal Disease, COPD: Chronic Obstructive Pulmonary Disease

Disclosures:

Mohamed Abdallah indicated no relevant financial relationships.

Anders Westanmo indicated no relevant financial relationships.

Susan Lou indicated no relevant financial relationships.

Brian Hanson: Motus GI – Consultant.

Andrew Reinink indicated no relevant financial relationships.

Willie Johnson indicated no relevant financial relationships.

Mohammad Bilal: Boston Scientific – Consultant.

Mohamed Abdallah, MD¹, Anders Westanmo, PharmD², Susan Lou, MD³, Brian J. Hanson, MD², Andrew Reinink, MD³, Willie M. Johnson, MD⁴, Mohammad Bilal, MD². P0559 - Safety and Efficacy of Over-The-Scope Clip Systems in Patients Undergoing Gastrointestinal Endoscopy with Moderate Sedation: A Preliminary Analysis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.