Pedunculated Colorectal PolypsNCT06097637
Underwater Endoscopic Mucosal Resection Versus Metal Clips With Hot Snare Polypectomy for Resection of Big Pedunculated Colorectal Polyps
A study testing underwater endoscopic mucosal resection and hot snare polypectomy in people with Pedunculated Colorectal Polyps and Haemorrhage, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Endoscopic resection of pedunculated polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedunculated polyps with different pedicle sizes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pedunculated Colorectal Polyps, Haemorrhage
- What is being tested?
- underwater endoscopic mucosal resection and hot snare polypectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2023to 31 Aug 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing endoscopic resection of small and medium pedicled polyps in the First Affiliated Hospital of Ningbo University from October 2023 to August 2026;
- Age 18-75 years old;
- Patients who voluntarily agreed to participate in this study and signed informed consent.
Who cannot join
- Persons under 18 years of age
- Persons unwilling or unable to provide informed consent
- Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months
- Malignant polyps have infiltrated the pedicle
- Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea
- Patients with inadequate intestinal preparation
- Patients with lifelong anticoagulant therapy or severe bleeding diseases, patients who have recently taken anticoagulant drugs or antiplatelet drugs (within 1 week)
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Lei Xu, MD, +86-13486659126, xulei22@163.com
About this study
Official title: Underwater Endoscopic Mucosal Resection Versus Metal Clips With Hot Snare Polypectomy for Resection of Big Pedunculated Colorectal Polyps: A Randomized Controlled Trial
Endoscopic resection of pedunculated polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedunculated polyps with different pedicle sizes. The head larger than 20mm or pedicle larger than 5mm are defined as large pedunculated polyps, which are at greater risk of bleeding. Current guidelines recommend hot removal by snare following preoperative saline injection, ligation of the pedicle with a nylon ring or metal clip, depending on the size of the polyp head and pedicle. However, the use of snares and metal clamps does not appear to reduce delayed postoperative bleeding, and the technical requirements of nylon ligation are relatively high. Recent studies have found that Underwater endoscopic mucosal resection (UEMR) is also safe and effective for the treatment of large and medium colorectal sessile polyps. Therefore, it is still necessary to further explore new safe and effective endoscopic resection strategies and techniques.
- Conditions
- Pedunculated Colorectal Polyps, Haemorrhage
- Being tested
- underwater endoscopic mucosal resection, hot snare polypectomy
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
underwater endoscopic mucosal resectionOther
underwater endoscopic mucosal resection achieves similar rates of complete resection with comparable safety, with lower rates of recurrence and fewer repeat procedures.
hot snare polypectomyOther
Current guidelines recommend preoperative hot snare polypectomy after preoperative saline injection, nylon ring, or metal clip ligation of the tip and pedicle of the polyps
| Study group | Role | What they receive |
|---|---|---|
| underwater endoscopic mucosal resection | Experimental | underwater endoscopic mucosal resection for resection of big pedunculated colorectal polyps Receives: Other: underwater endoscopic mucosal resection |
| hot snare polypectomy | Active comparator | hot snare polypectomy for resection of big pedunculated colorectal polyps Receives: Other: hot snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of immediate bleeding
Immediate bleeding was defined as an intraoperative bleeding immediately after Immediate bleeding staging: If there is no bleeding, fill in 'none'; Level 1, spontaneous hemostasis within 60 seconds; Level 2, continuous small bleeding for more than 60 seconds; Level 3, continuous bleeding for more than 60 seconds requires endoscopic treatment; Level 4, arterial spray
Measured: 1 Minutes
Secondary outcomes (1)
delayed hemorrhage
Any symptoms of gastrointestinal bleeding (e. g. hematochezia) occurred within 30 days after polypectomy and were classified as mild or severe according on the severity of the bleeding
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start19 Oct 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pedunculated Colorectal PolypsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097637
- Sponsor's protocol ID
- 2023-139A-YJ01
- Status last verified
- Jul 2024
- First submitted
- 18 Oct 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Endoscopic Mucosal Resection Versus Metal Clips With Hot Snare Polypectomy for Resection of Big Pedunculated Colorectal Polyps: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06097637
- Acronym / sponsor ID
- 2023-139A-YJ01
- Conditions
- Pedunculated Colorectal Polyps, Haemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
Endoscopic resection of pedunculated polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedunculated polyps with different pedicle sizes. The head larger than 20mm or pedicle larger than 5mm are defined as large pedunculated polyps, which are at greater risk of bleeding. Current guidelines recommend hot removal by snare following preoperative saline injection, ligation of the pedicle with a nylon ring or metal clip, depending on the size of the polyp head and pedicle. However, the use of snares and metal clamps does not appear to reduce delayed postoperative bleeding, and the technical requirements of nylon ligation are relatively high. Recent studies have found that Underwater endoscopic mucosal resection (UEMR) is also safe and effective for the treatment of large and medium colorectal sessile polyps. Therefore, it is still necessary to further explore new safe and effective endoscopic resection strategies and techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| underwater endoscopic mucosal resection | Experimental | Other: underwater endoscopic mucosal resectionunderwater endoscopic mucosal resection for resection of big pedunculated colorectal polyps |
| hot snare polypectomy | Active comparator | Other: hot snare polypectomyhot snare polypectomy for resection of big pedunculated colorectal polyps |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing endoscopic resection of small and medium pedicled polyps in the First Affiliated Hospital of Ningbo University from October 2023 to August 2026;
- Age 18-75 years old;
- Patients who voluntarily agreed to participate in this study and signed informed consent.
Key exclusion criteria (8 listed)
- Persons under 18 years of age
- Persons unwilling or unable to provide informed consent
- Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months
- Malignant polyps have infiltrated the pedicle
- Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea
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 endoscopic mucosal resectionunderwater endoscopic mucosal resection achieves similar rates of complete resection with comparable safety, with lower rates of recurrence and fewer repeat procedures. | Other | underwater endoscopic mucosal resection |
| hot snare polypectomyCurrent guidelines recommend preoperative hot snare polypectomy after preoperative saline injection, nylon ring, or metal clip ligation of the tip and pedicle of the polyps | Other | hot snare polypectomy |
Primary outcome
Prevalence of immediate bleeding
Time frame: 1 Minutes
Immediate bleeding was defined as an intraoperative bleeding immediately after Immediate bleeding staging: If there is no bleeding, fill in 'none'; Level 1, spontaneous hemostasis within 60 seconds; Level 2, continuous small bleeding for more than 60 seconds; Level 3, continuous bleeding for more than 60 seconds requires endoscopic treatment; Level 4, arterial spray
1 secondary outcome
delayed hemorrhage
Time frame: 2 weeks and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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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.
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 endoscopic mucosal resection and hot snare polypectomy in people with Pedunculated Colorectal Polyps and Haemorrhage, run by Ningbo No. 1 Hospital 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 3 inclusion and 8 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 18 Dec 2024. 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 Lei Xu (+8613486659126, xulei22@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of immediate bleeding (time frame: 1 Minutes). 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 18 Dec 2024.