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Completed

NCT Number: NCT04214678

DeFect cLOsure After Colonic ESD With underwaTer Technique

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Underwater clip closure

Procedure

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

Conventional clip closure

Procedure

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

Primary outcomes

  1. Time required to complete clip closure of mucosal defect

    Time frame: Within 1 hour

    o Defined as the time from completion of prophylactic coagulation till the final clip application (min)

Secondary outcomes

  1. Technical success of complete closure of defect (%)

    Time frame: Within 1 hour

  2. Total time for endoscopic procedure (min)

    Time frame: Within 1 hour

  3. Number of endoscopic clip used for closure

    Time frame: Within 1 hour

  4. Rate of Haemorrhage

    Time frame: 30 days

    Post-procedural per rectal bleeding that requires intervention or blood product transfusion

  5. Rate of Perforation

    Time frame: 30 days

    Abdominal pain with radiological evidence of intra-abdominal free gas suggesting perforation

  6. Rate of Post-polypectomy electrocoagulation syndrome

    Time frame: 30 days

    Abdominal pain without radiological evidence of intra-abdominal free gas to suggest perforation

  7. Rate of Any other adverse event related to the procedure

    Time frame: 30 days

    Other adverse event

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: FLOAT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2020
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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