Endoscopic Closure of Gastric ESD Defect

NCT04282707 | Unknown DMC

• 1 other identifier: CRE-2019.561
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endoscopic submucosal dissection, defect closure

Outcome Measures

Primary Outcomes (1)

• Technical success rate

  Rate of complete closure of the ESD defect in the index endoscopic resection procedure

  1 day

Secondary Outcomes (3)

• Clinical success rate

  2 weeks

• Rate of Post-ESD haemorrhage

  30 days

• Rate of adverse events of the procedure

  30 days

Study Arms (2)

Endoscopic closure

EXPERIMENTAL

Prospectively collected patients for gastric ESD and would undergo closure of defect

Procedure: Endoscopic closure of ESD defect

Historical control

OTHER

Historical control of patients who underwent gastric ESD

Other: Gastric ESD without closure of ESD defect

Interventions

Endoscopic closure of ESD defect PROCEDURE

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

Endoscopic closure

Gastric ESD without closure of ESD defect OTHER

Historical control with patients undergoing ESD without closure of ESD defect

Historical control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective gastric endoscopic submucosal dissection for epithelial lesions
• Procedure deemed at high risk of post-procedural hemorrhage due to the following:
• End stage renal disease (Estimated GFR \<15ml/min)
• Patients on anti-thrombotic agents (Double antiplatelet, warfarin or direct oral anticoagulants)
• Post ESD mucosal defect size \>4cm
• Target subjects receiving sufficient briefing from the attending physician regarding the content of this study and providing informed consent for participation
• Over 20 years of age

You may not qualify if:

• Recurrent / remnant lesion after previous endoscopic resection
• Lesions arising from surgical anastomotic site, such as gastrojejunostomy / gastroduodenostomy.
• Marked electrolyte abnormalities
• Allergic to components of injection solutions: Epinephrine, hyaluronic acid etc
• Other cases deemed by the examining physician as unsuitable for safe treatment
• Patients who refused to participate

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Hon Chi Yip, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Chi Yip, MBChB

CONTACT

+852 35052627; hcyip@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate consultant

Model Details: Prospectively collected cohort of 30 patients. Compared with historical cohort.

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: July 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: March 31, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)