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

NCT06097637 | Recruiting

• 1 other identifier: 2023-139A-YJ01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  1 Minutes

Secondary Outcomes (1)

• delayed hemorrhage

  2 weeks and 4 weeks

Other Outcomes (1)

• Immediate perforation rate

  30 seconds

Study Arms (2)

underwater endoscopic mucosal resection

EXPERIMENTAL

underwater endoscopic mucosal resection for resection of big pedunculated colorectal polyps

Other: underwater endoscopic mucosal resection

hot snare polypectomy

ACTIVE COMPARATOR

hot snare polypectomy for resection of big pedunculated colorectal polyps

Other: hot snare polypectomy

Interventions

underwater endoscopic mucosal resection OTHER

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

underwater endoscopic mucosal resection

hot snare polypectomy 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

hot snare polypectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Xu

CONTACT

+8613486659126; xulei22@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: October 19, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-07

Locations

CN (1)