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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNingbo No. 1 Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • underwater endoscopic mucosal resection

    Other intervention

    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

    Other intervention

    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

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: underwater endoscopic mucosal resectionExperimental treatment 1 intervention
Group B: hot snare polypectomyActive comparator 1 intervention

Trial outcomes

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

Time frame
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

Time frame
2 weeks and 4 weeks

Other outcomes

1

Immediate perforation rate

perforation

Time frame
30 seconds

Sponsors and contacts

Click on the lead sponsor to view all of their trials.