NCT06097650

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 stalk sizes. Small pedunculated polyps with heads smaller than 20mm and stalks less than or equal to 5mm are defined as having a relatively small risk of bleeding. Preliminary studies in recent years suggest that the use of cold snare polypectomy for small pedunculated polyps may also be a safe resection strategy. However, for small pedunculated polyps, ASGE and ESGE guidelines currently recommend hot snare polypectomy in the middle and lower pedicles (evidence level medium). Therefore, the provision of high-quality clinical evidence related to cold resection techniques in the resection strategy of small pedunculated polyps may provide a basis for revision of guidelines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

October 18, 2023

Last Update Submit

July 20, 2025

Conditions

Outcome Measures

Primary 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

    2 days, 2 weeks and 4 weeks

Secondary Outcomes (1)

  • Prevalence of immediate bleeding

    1 Minutes

Other Outcomes (1)

  • Immediate perforation rate

    Immediate

Study Arms (2)

cold snare polypectomy

EXPERIMENTAL

cold snare polypectomy for resection of small pedunculated colorectal polyps

Other: cold snare polypectomy

hot snare polypectomy

ACTIVE COMPARATOR

hot snare polypectomy for resection of small pedunculated colorectal polyps

Other: hot snare polypectomy

Interventions

Histological analyses suggest that cold snare polypectomy causes less damage to blood vessels in the submucosal layers, which results in a reduced incidence of hemorrhage

cold snare polypectomy

According to current clinical guidelines, hot snare polypectomy is the recommended standard technique for the resection of pedunculated colorectal polyps.

hot snare polypectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients undergoing endoscopic resection of small pedicled polyps in the First Affiliated Hospital of Ningbo University, The Third People's Hospital Health Care Group of Cixi, Ninghai Second Hospital and Renmin Hospital of Yuyao City from October 2023 to August 2026; 2. Patients who voluntarily agreed to participate in this study and signed informed consent.

You may not qualify if:

  • \. 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.polyps with endoscopic features suspicious for carcinoma 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

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 18, 2023

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations