MedDataX Logo

Underwater Endoscopic Mucosal Resection Versus Metal Clips With Hot Snare Polypectomy for Resection of Big Pedunculated Colorectal Polyps

NCT ID: NCT06097637

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pedunculated Colorectal Polyps Haemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

underwater endoscopic mucosal resection

underwater endoscopic mucosal resection for resection of big pedunculated colorectal polyps

Group Type EXPERIMENTAL

underwater endoscopic mucosal resection

Intervention Type OTHER

underwater endoscopic mucosal resection achieves similar rates of complete resection with comparable safety, with lower rates of recurrence and fewer repeat procedures.

hot snare polypectomy

hot snare polypectomy for resection of big pedunculated colorectal polyps

Group Type ACTIVE_COMPARATOR

hot snare polypectomy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

underwater endoscopic mucosal resection

underwater endoscopic mucosal resection achieves similar rates of complete resection with comparable safety, with lower rates of recurrence and fewer repeat procedures.

Intervention Type OTHER

hot snare polypectomy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients undergoing endoscopic resection of small and medium pedicled polyps in the First Affiliated Hospital of Ningbo University from October 2023 to August 2026;
2. Age 18-75 years old;
3. Patients who voluntarily agreed to participate in this study and signed informed consent.

Exclusion Criteria

1. Persons under 18 years of age
2. Persons unwilling or unable to provide informed consent
3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months
4. Malignant polyps have infiltrated the pedicle
5. Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea
6. Patients with inadequate intestinal preparation
7. Patients with lifelong anticoagulant therapy or severe bleeding diseases, patients who have recently taken anticoagulant drugs or antiplatelet drugs (within 1 week)
8. Pregnant or lactating
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lei Xu

Role: CONTACT

Phone: +8613486659126

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lei Xu, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-139A-YJ01

Identifier Type: -

Identifier Source: org_study_id