MedTrace Logo

Endoscopic Closure of Gastric ESD Defect

NCT04282707 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-04

No results posted yet for this study

Summary

This is a pilot study to investigate the usefulness of closure of mucosal defect after gastric endoscopic submucosal dissection (ESD) in patients that are at high risk of post-procedural haemorrhage. Delayed haemorrhage is still an important adverse event of ESD, occurring more frequently for gastric lesions. Risk factors identified for delayed haemorrhage include chronic kidney disease, use of antithrombotic agent, lesion size \>20mm, specimen size \>30mm. Current established methods to prevent this complications could not completely eliminate the chance of bleeding, especially among high-risk cases. Closure of ESD defect may prevent ongoing exposure of submucosal vessels to gastric acid, and further reduce the risk of delayed haemorrhage. The investigators conduct this study to investigate the effect of closing the defect with endoscopic clips and loop. 30 patients who are undergoing gastric ESD deemed high risk of delayed haemorrhage would be recruited, with closure of defect after resection. The rate of delayed haemorrhage would be compared with historical cohort of patients.

Conditions

  • Gastric Dysplasia
  • Gastric Cancer in Situ

Interventions

PROCEDURE

Endoscopic closure of ESD defect

Closure of ESD defect would be performed with clip loop purse string technique

OTHER

Gastric ESD without closure of ESD defect

Historical control with patients undergoing ESD without closure of ESD defect

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Hon Chi Yip, MBChB · Chinese University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-02-28
Completion
2022-03-31

Countries

  • Hong Kong

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 NCT04282707 on ClinicalTrials.gov