A New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection

Feasibility of a New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection: a Prospective Randomized Controlled Study

Studies have shown that postoperative inflammation can be relieved by clipping the wound, and can reduce the bleeding rate and perforation rate.Scholars at home and abroad have proposed the use of adhesives and circular surgical lines to clamp the wound.In 2019, Satoshi Abiko and others proposed the use of double-loop clips technology to clamp the wound, and make double-loop clips of appropriate length outside the body.Therefore, our study is a prospective randomized controlled study to explore whether the double-loop clips technique is safe and effective for larger wounds in daily clinical work.

Study Overview

• Status: Recruiting
• Conditions: Polyps; Closure; Delay
• Intervention / Treatment: Device: double-loop clips; Device: Titanium Clip

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei f Xu; Phone Number: +8613486659126; Email: xulei22@163.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Recruiting
      • Ningbo First Hospital
      • Contact: Lei Xu, MD; Phone Number: +86-13486659126; Email: xulei22@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with wounds larger than 20mm
• Patients aged 18 to 75 years old

Exclusion Criteria:

• Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
• Pregnant or breastfeeding.
• Allergy or intolerance to any study drug.
• Patients who have taken anticoagulant drugs (aspirin, clopidogrel, etc.) in the past week but are contraindicated for endoscopic polyp treatment.
• Other imaging findings suggest patients with advanced cancer.
• Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLCT; After finding polyps that meet the inclusion criteria, the surgical method for resection was selected according to the operator's preferences, and the experimental group used double-loop coil clamp technology to treat the wound.	Device: double-loop clips; a new ligation method using the double-loop clips (D-L clips) technique
Active Comparator: Traditional technology; After finding polyps that meet the inclusion criteria, the surgical method for resection was selected according to the operator's preferences.The control group used the traditional hemostatic clip technique to treat the wound	Device: Titanium Clip; the Titanium Clip; Other Names: Traditional technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete closure rate	Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when there was no remaining visible mucosal defect and clips were <1cm apart.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time	The time from when the first clip is hit until it is completely closed	1 hour
Closing speed	Resection area divided by clamping time	1 hour

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
• Other Study ID Numbers: DLCT-1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No