MedTrace Logo

Purse String Suture Device vs. Endoclip for Immediate Endoscopic Procedure Associated Gastrointestinal Perforation

NCT03053232 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-02-15

No results posted yet for this study

Summary

Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers. Endoscopic procedure associated gastrointestinal perforation is one of the the most severe complications, which is associated with high morality and needs timely detection and effective treatment in clinical practice.Over 90% procedure associated gastrointestinal perforation occurs immediately within 24 h after endoscopic procedure.Endoclips have been widely used in closing the immediate gastrointestinal perforations, but the location of the endoclips could influence the effective rate, limiting its application. In addition, multiple endoclips should be placed under endoscopy for a relatively large perforation, which could increase the medical cost and the procedure time. At recent, a new purse string suture device (LeoMed, China) has been developed by us and introduced to the clinicalmanagement of such patients with procedure associated gastrointestinal perforations. Clinical data validated that the usage of this new purse string suture in treating immediate procedure associated perforations was greatly convenient and effective with very low reoperation rate and postoperative complication rate. A specially designed loop was equipped in this device, which could be tightened under endoscopy. Thus, compared with the placement of endoclips, this device could be more convenient and effective in completely closing the gastrointestinal perforations.This study will test whether purse string suture device will increase the effectiveness of closingimmediate procedure associated gastrointestinal perforationsunder endoscopyin a randomized controlled trialby comparing the use of purse string suture deviceand endoclips.

Conditions

  • Intervention
  • Gastrointestinal Perforation

Interventions

DEVICE

Purse string suture device

Using purse string suture device to close gastrointestinal perforation under endoscopy.

DEVICE

Endoclips

Using endoclips to close gastrointestinal perforation under endoscopy.

Sponsors & Collaborators

  • Affiliated Hospital to Academy of Military Medical Sciences

    lead OTHER

Principal Investigators

  • Yan Liu, M.D., Ph.D. · Affiliated Hospital to Academy of Military Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-10-31
Completion
2018-01-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03053232 on ClinicalTrials.gov