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DeFect cLOsure After Colonic ESD With underwaTer Technique

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04214678
Acronym
FLOAT
Enrollment
64
Registered
2020-01-02
Start date
2020-07-01
Completion date
2023-06-30
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyp

Keywords

Endosocpic submucosal dissection, Underwater clip closure

Brief summary

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.

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.

Interventions

PROCEDUREUnderwater clip closure

Closure of post-resection defect with endoscopic clips by underwater technique

PROCEDUREConventional clip closure

Closure of post-resection defect with endoscopic clip by conventional technique

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time required to complete clip closure of mucosal defectWithin 1 houro Defined as the time from completion of prophylactic coagulation till the final clip application (min)

Secondary

MeasureTime frameDescription
Total time for endoscopic procedure (min)Within 1 hour
Number of endoscopic clip used for closureWithin 1 hour
Rate of Haemorrhage30 daysPost-procedural per rectal bleeding that requires intervention or blood product transfusion
Technical success of complete closure of defect (%)Within 1 hour
Rate of Post-polypectomy electrocoagulation syndrome30 daysAbdominal pain without radiological evidence of intra-abdominal free gas to suggest perforation
Rate of Any other adverse event related to the procedure30 daysOther adverse event
Rate of Perforation30 daysAbdominal pain with radiological evidence of intra-abdominal free gas suggesting perforation

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026