DeFect cLOsure After Colonic ESD With underwaTer Technique (FLOAT)

DeFect cLOsure After Colonic ESD With underwaTer Technique Versus Conventional Clip : a Randomized Controlled Trial

This is a single centre randomised controlled study comparing underwater clip closure versus conventional gas insufflation clip closure of post-resection defect in patients undergoing colonic endoscopic resection. The investigators hypothesize that underwater clip closure would be faster than conventional closure under gas insufflation.

Study Overview

• Status: Completed
• Conditions: Colonic Polyp
• Intervention / Treatment: Procedure: Underwater clip closure; Procedure: Conventional clip closure

Detailed Description

Endoscopic submucosal dissection (ESD) is a minimally invasive technique that has been increasingly applied to superficial colorectal tumours over the past two decades (1, 2). Although serious complications with this procedure are uncommon, both significant delayed haemorrhage (1-2%) and perforation (4-6%) are recognised complications (3). Although perforation is generally recognised and treated at time of endoscopy, delayed bleeding often requires repeat readmission and endoscopy for haemorrhage control. There is growing evidence to support prophylactic clip closure of mucosal defects to reduce incidences of delayed haemorrhage.

Prophylactic clip closure of mucosal defects (≥20mm) after colonic ESD is supported by large retrospective case series. In a series of 524 lesions in 463 patients, Liaquat et al. (2013) reported prophylactic clipping of resection sites to close mucosal defects versus non-closure, reduced delayed haemorrhage (9.7% vs 1.8%) (4). Ogiyama et al. (2018) reported similar findings in a series of 156 lesions (0% vs 8.2%, p=0.008) (5).

Prophylactic defect closure also has a theoretical benefit in reducing delayed perforation from unrecognised muscular breach during dissection. Though it is recognised that there is a paucity of evidence to support mucosal apposition in reducing delayed perforation rates (~0.2%) (3). This is likely due to the underpowered published studies and a very low event rate.

For these reasons, it has been routine practice of many endoscopists for clip closure of mucosal defects after endoscopic resection of large colorectal neoplasia. However, this technique remains technically challenging within the narrow colonic space and at times may not be feasible. The 'underwater closure technique' in mucosal defect closure of colonic and duodenal endoscopic resections has promising early results. Compared to conventional CO2 insufflation clip placement, at the time of mucosal closure this technique applies luminal water infusion to 'float' the resection borders and downsize the target. Early experience suggests this technique facilitates easier apposition of resection borders and complete closure. There are currently no randomized trials comparing these clip closure techniques.

The aim of the study is to evaluate whether prophylactic underwater closure technique facilitates easier ESD mucosal defect closure compared to conventional clip closure.

This is a single centre prospective randomized controlled trial. Consecutive patients undergoing endoscopic resection for colonic lesions would be recruited. Participants would be randomized to receive prophylactic conventional clip closure versus underwater technique.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing elective endoscopic resection
• Colorectal superficial neoplasm with a resultant mucosal defect of ≥20mm
• Age >18 years old

Exclusion Criteria:

• Patients on anticoagulation (Warfarin or other direct oral anticoagulants)
• Muscular perforation during the endoscopic resection
• Incomplete endoscopic resection
• Lesions arising from surgical anastomotic site
• Marked electrolyte abnormalities
• Other cases deemed by the examining physician as unsuitable for safe treatment
• Patients who refused to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Underwater clip closure; The post-resection defect is closed using endoscopic clips with underwater technique	Procedure: Underwater clip closure; Closure of post-resection defect with endoscopic clips by underwater technique
Active Comparator: Conventional clip closure; The post-resection defect is closed using endoscopic clips with conventional gas insufflation (CO2)	Procedure: Conventional clip closure; Closure of post-resection defect with endoscopic clip by conventional technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required to complete clip closure of mucosal defect	o Defined as the time from completion of prophylactic coagulation till the final clip application (min)	Within 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success of complete closure of defect (%)		Within 1 hour
Total time for endoscopic procedure (min)		Within 1 hour
Number of endoscopic clip used for closure		Within 1 hour
Rate of Haemorrhage	Post-procedural per rectal bleeding that requires intervention or blood product transfusion	30 days
Rate of Perforation	Abdominal pain with radiological evidence of intra-abdominal free gas suggesting perforation	30 days
Rate of Post-polypectomy electrocoagulation syndrome	Abdominal pain without radiological evidence of intra-abdominal free gas to suggest perforation	30 days
Rate of Any other adverse event related to the procedure	Other adverse event	30 days

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Hon Chi Yip, MBChB, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: December 28, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Endosocpic submucosal dissection; Underwater clip closure
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
• Other Study ID Numbers: CRE 2019.558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No