Colonic PolypFLOATNCT04214678
DeFect cLOsure After Colonic ESD With underwaTer Technique
A study testing Underwater clip closure and Conventional clip closure in people with Colonic Polyp, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Underwater clip closure and Conventional clip closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective endoscopic resection
- Colorectal superficial neoplasm with a resultant mucosal defect of ≥20mm
- Age >18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonic Polyp
- Being tested
- Underwater clip closure, Conventional clip closure
- Keywords
- Endosocpic submucosal dissection, Underwater clip closure
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underwater clip closureProcedure or surgery
Closure of post-resection defect with endoscopic clips by underwater technique
Conventional clip closureProcedure or surgery
Closure of post-resection defect with endoscopic clip by conventional technique
| Study group | Role | What they receive |
|---|---|---|
| Underwater clip closure | Experimental | The post-resection defect is closed using endoscopic clips with underwater technique Receives: Procedure: Underwater clip closure |
| Conventional clip closure | Active comparator | The post-resection defect is closed using endoscopic clips with conventional gas insufflation (CO2) Receives: Procedure: Conventional clip closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to complete clip closure of mucosal defect
- Defined as the time from completion of prophylactic coagulation till the final clip application (min)
Measured: Within 1 hour
Secondary outcomes (7)
Technical success of complete closure of defect (%)
Measured: Within 1 hour
Total time for endoscopic procedure (min)
Measured: Within 1 hour
Number of endoscopic clip used for closure
Measured: Within 1 hour
Rate of Haemorrhage
Post-procedural per rectal bleeding that requires intervention or blood product transfusion
Measured: 30 days
Rate of Perforation
Abdominal pain with radiological evidence of intra-abdominal free gas suggesting perforation
Measured: 30 days
Rate of Post-polypectomy electrocoagulation syndrome
Abdominal pain without radiological evidence of intra-abdominal free gas to suggest perforation
Measured: 30 days
Rate of Any other adverse event related to the procedure
Other adverse event
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
- Investigators
- Hon Chi Yip, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214678
- Sponsor's protocol ID
- CRE 2019.558
- Acronym
- FLOAT
- Status last verified
- Aug 2023
- First submitted
- 28 Dec 2019
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeFect cLOsure After Colonic ESD With underwaTer Technique Versus Conventional Clip : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04214678
- Acronym / sponsor ID
- FLOAT / CRE 2019.558
- Conditions
- Colonic Polyp
- Keywords
- Endosocpic submucosal dissection, Underwater clip closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underwater clip closure | Experimental | Procedure: Underwater clip closureThe post-resection defect is closed using endoscopic clips with underwater technique |
| Conventional clip closure | Active comparator | Procedure: Conventional clip closureThe post-resection defect is closed using endoscopic clips with conventional gas insufflation (CO2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective endoscopic resection
- Colorectal superficial neoplasm with a resultant mucosal defect of ≥20mm
- Age >18 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Underwater clip closureClosure of post-resection defect with endoscopic clips by underwater technique | Procedure or surgery | Underwater clip closure |
| Conventional clip closureClosure of post-resection defect with endoscopic clip by conventional technique | Procedure or surgery | Conventional clip closure |
Primary outcome
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)
7 secondary outcomes
Technical success of complete closure of defect (%)
Time frame: Within 1 hour
Total time for endoscopic procedure (min)
Time frame: Within 1 hour
Number of endoscopic clip used for closure
Time frame: Within 1 hour
Rate of Haemorrhage
Time frame: 30 days
Rate of Perforation
Time frame: 30 days
Rate of Post-polypectomy electrocoagulation syndrome
Time frame: 30 days
Rate of Any other adverse event related to the procedure
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hon Chi Yip, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underwater clip closure and Conventional clip closure in people with Colonic Polyp, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to complete clip closure of mucosal defect (time frame: Within 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.