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1. Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

Author

Ayla S. Turan, Leon M. G. Moons, Ramon-Michel Schreuder, Erik J. Schoon, Jochim S. Terhaar sive Droste, Ruud W. M. Schrauwen, Jan Willem Straathof, Barbara A. J. Bastiaansen, Matthijs P. Schwartz, Wouter L. Hazen, Alaa Alkhalaf, Daud Allajar, Muhammed Hadithi, Bas W. van der Spek, Dimitri G. D. N. Heine, Adriaan C. I. T. L. Tan, Wilmar de Graaf, Jurjen J. Boonstra, Fia J. Voogd, Robert Roomer, Rogier J. J. de Ridder, Wietske Kievit, Peter D. Siersema, Paul Didden, Erwin J. M. van Geenen, and on behalf of the Dutch EMR Study Group

Subjects
Prophylactic clipping, EMR, Colonic polyp, Delayed bleeding, Clip artifact, Medicine (General), R5-920
Abstract

Abstract Background Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk. Methods The CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of

Published
2021
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2. Application of a novel self-assembling peptide to prevent hemorrhage after EMR, a feasibility and safety study

Author

Ayla S. Turan, Peter D. Siersema, Erwin J M van Geenen, and Elsa Soons

Subjects
medicine.medical_specialty, genetic structures, Endoscopic Mucosal Resection, Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0], Endoscopic mucosal resection, Hemorrhage, Topical agent, Article, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Prospective Studies, Esophagus, Prospective cohort study, Adverse effect, business.industry, Prophylaxis, Feasibility, Exploratory analysis, Hepatology, Surgery, medicine.anatomical_structure, Treatment Outcome, 030220 oncology & carcinogenesis, Duodenum, Delayed bleeding, Feasibility Studies, 030211 gastroenterology & hepatology, Safety, business, Peptides, Abdominal surgery
Abstract

Background A novel self-assembling peptide (SAP) can be applied to the post-endoscopic mucosal resection (EMR) defect to treat oozing bleedings. It has been suggested to stimulate early healing of damaged vessels. We hypothesized that SAP application could prevent delayed bleeding (DB) after EMR and performed a prospective cohort study to determine feasibility and safety. Methods A total of 48 consecutive patients who underwent EMR between June 2018 and August 2019 for large lesions in the esophagus, duodenum (> 1 cm) or colorectum (> 2 cm) were treated with adjuvant SAP application. Duration and ease of SAP application were measured, as well as DB outcome. Results The EMR defects of 48 patients were treated with SAP; 17 in the esophagus, 13 in the duodenum and 18 in the colorectum. SAP was easy to apply on the EMR defect with a median duration of 2.0 min. A dose of 3 cc was generally enough to cover a defect between 10 and 50 mm. An exploratory analysis of the prophylactic ability of SAP showed that 15.9% of patients (7/44) treated with SAP still had a DB, mostly in the duodenum (4/11). No adverse events related to gel exposure were reported. Conclusions SAP application after EMR was found to be feasible and safe, and did not delay the procedure; however, DB was still relatively common. Future comparative studies are needed to evaluate whether SAP is able to reduce DB after EMR, particularly for lesions with an increased bleeding risk, such as in the duodenum.

Published
2020

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