Post-polypectomy BleedingAPC、HSPNCT05250518
Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy
A study testing argon plasma coagulation and clip closure in people with Post-polypectomy Bleeding and Colorectal Polyp, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-polypectomy Bleeding, Colorectal Polyp
- What is being tested?
- argon plasma coagulation and clip closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,017 participants
- Where
- 1 siteChina
- Study dates
- Mar 2022to Oct 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
- age>18 years
- the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）
- head diameter≥ 10 mm
- HSP indications were met and no contraindications were found
- patients (or the legal representative/guardian) with informed consent
Who cannot join
- ASA Grade Ⅲ or above, or end-stage disease of major organs (such as malignancy, heart failure, chronic obstructive pulmonary disease, end-stage renal disease and so on)
- coagulation dysfunction (INR ≥ 1.5, PLT < 50×10 ^9 / L)
- use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation
- there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient
- incomplete closure of clips (complete closure: spacing between adjacent clips < 1cm)
- APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB
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- surgical treatment, vascular intervention, or blood products were used during the operation
- use other methods to prevent PPB
- the bleeding site was not confirmed by endoscopy
- history of intestinal surgery
- menstruation or pregnancy
- not following medical advice
- participated in other clinical trials and signed its informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Argon Plasma Coagulation and Clip Closure for the Prophylaxis of Colorectal Post-polypectomy Bleeding After Hot Snare Polypectomy: a Multicenter, Randomized and Controlled Study
Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.
Read the detailed description
This is a multicenter, randomized and controlled study. It aims to discuss the efficacy and safety of argon plasma coagulation（APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）, and analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.
According to the prophylaxis measures, patients enrolled in this study will be randomized into the control group, APC group and Clip group. It will collect participants' data of baseline character, postoperative and follow-up. All statistical analyses will be performed by SPSS 26.0 and Tree Age Pro 2011.
Based on the previous studies, it is presumed that the rate of PPB for the control group, Clip group and APC group is 8%, 2% and 2%. Given two-side testing, an alpha of 0.05 and a power of 90%, allowing for a 5% dropout rate, the smallest sample size is 1287.
- Conditions
- Post-polypectomy Bleeding, Colorectal Polyp
- Being tested
- argon plasma coagulation, clip closure
- Keywords
- hot snare polypectomy, argon plasma coagulation, clip closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
argon plasma coagulationProcedure or surgery
After hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding.
clip closureProcedure or surgery
After hot snare polypectomy, participants will be randomized assigned to the Clip group for complete closure(spacing between adjacent clips < 1cm) to prevent colorectal post-procedure bleeding.
| Study group | Role | What they receive |
|---|---|---|
| the control group | No intervention | The control group will receive no prophylaxis of post-procedure bleeding. |
| APC group | Experimental | The APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation. Receives: Procedure: argon plasma coagulation |
| Clip group | Experimental | The Clip group will receive prophylaxis of post-procedure bleeding with clip closure. Receives: Procedure: clip closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of re-bleeding
the rate of re-bleeding within 30 days after operation
Measured: 30 days after HSP
Secondary outcomes (3)
Location of re-bleeding sites
the original polyps' location of re-bleeding sites: cecum, ascending colon, colonic hepatic flexure, transverse colon, colonic splenic flexure , descending colon, sigmoid colon, rectum
Measured: 30 days after HSP
Other postoperative complications
Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.)
Measured: 30 days after HSP
Expenses of prevention
Expenses of argon plasma coagulation and clips
Measured: the 1 day of discharge from medical centers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-polypectomy BleedingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,017 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
- Investigators
- Mingkai Chen, Ph.D & M.D, Study director, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250518
- Sponsor's protocol ID
- WDRY2022-K018
- Acronym
- APC、HSP
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Argon Plasma Coagulation and Clip Closure for the Prophylaxis of Colorectal Post-polypectomy Bleeding After Hot Snare Polypectomy: a Multicenter, Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT05250518
- Acronym / sponsor ID
- APC、HSP / WDRY2022-K018
- Conditions
- Post-polypectomy Bleeding, Colorectal Polyp
- Keywords
- hot snare polypectomy, argon plasma coagulation, clip closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,017 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 22 Feb 2022 (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.
Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.
Detailed description
This is a multicenter, randomized and controlled study. It aims to discuss the efficacy and safety of argon plasma coagulation（APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）, and analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.
According to the prophylaxis measures, patients enrolled in this study will be randomized into the control group, APC group and Clip group. It will collect participants' data of baseline character, postoperative and follow-up. All statistical analyses will be performed by SPSS 26.0 and Tree Age Pro 2011.
Based on the previous studies, it is presumed that the rate of PPB for the control group, Clip group and APC group is 8%, 2% and 2%. Given two-side testing, an alpha of 0.05 and a power of 90%, allowing for a 5% dropout rate, the smallest sample size is 1287.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the control group | No intervention | –The control group will receive no prophylaxis of post-procedure bleeding. |
| APC group | Experimental | Procedure: argon plasma coagulationThe APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation. |
| Clip group | Experimental | Procedure: clip closureThe Clip group will receive prophylaxis of post-procedure bleeding with clip closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age>18 years
- the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）
- head diameter≥ 10 mm
- HSP indications were met and no contraindications were found
- patients (or the legal representative/guardian) with informed consent
Key exclusion criteria (13 listed)
- ASA Grade Ⅲ or above, or end-stage disease of major organs (such as malignancy, heart failure, chronic obstructive pulmonary disease, end-stage renal disease and so on)
- coagulation dysfunction (INR ≥ 1.5, PLT < 50×10 ^9 / L)
- use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation
- there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient
- incomplete closure of clips (complete closure: spacing between adjacent clips < 1cm)
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 |
|---|---|---|
| argon plasma coagulationAfter hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding. | Procedure or surgery | APC group |
| clip closureAfter hot snare polypectomy, participants will be randomized assigned to the Clip group for complete closure(spacing between adjacent clips < 1cm) to prevent colorectal post-procedure bleeding. | Procedure or surgery | Clip group |
Primary outcome
The rate of re-bleeding
Time frame: 30 days after HSP
the rate of re-bleeding within 30 days after operation
3 secondary outcomes
Location of re-bleeding sites
Time frame: 30 days after HSP
Other postoperative complications
Time frame: 30 days after HSP
Expenses of prevention
Time frame: the 1 day of discharge from medical centers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Mingkai Chen, Ph.D & M.D study director
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing argon plasma coagulation and clip closure in people with Post-polypectomy Bleeding and Colorectal Polyp, run by Renmin Hospital of Wuhan University at 1 site in China.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingkai Chen, Ph.D & M.D (+86 13720330580, chenmingkai@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of re-bleeding (time frame: 30 days after HSP). 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 22 Feb 2022.