Endoscopic Closure of Gastric ESD Defect
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|ClinicalTrials.gov Identifier: NCT04282707|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Dysplasia Gastric Cancer in Situ||Procedure: Endoscopic closure of ESD defect Other: Gastric ESD without closure of ESD defect||Not Applicable|
Endoscopic submucosal dissection (ESD) is an endoscopic technique aiming to achieve en-bloc resection of mucosal neoplastic lesion in the gastrointestinal tract. Since the first report of ESD in 2002, the indication of the procedure has been expanding. Over the years, large-scale prospective study of ESD in the stomach has been reported. It is now considered as the standard of treatment for early gastric cancer confined to the mucosa, achieving an excellent overall survival comparable to that of surgical resection.
As compared to conventional endoscopic mucosal resection (EMR), ESD is technically more challenging and also carries higher procedural risks. Important adverse events associated with gastric ESD include hemorrhage (intraoperative or delayed) and perforation. The reported incidence of delayed hemorrhage of gastric ESD is generally higher than that of esophageal or colorectal ESD5. A recent systematic review and meta-analysis identified risk factors for post-ESD delayed hemorrhage as follow: chronic kidney disease (OR 3.38), use of antithrombotic agent (OR 1.63), lesion size >20mm (OR 2.70), specimen size >30mm (OR 2.85).
Established methods of preventing post-ESD hemorrhage include the use of proton pump inhibitor (PPI) and prophylactic coagulation of visible vessels after ESD7-9. However, both methods could not completely eliminate the chance of bleeding, especially among high-risk cases. Additional strategies may be required to further reduce the risk of delayed hemorrhage. Recently, Kataoka Y et al investigated the use of polyglycolic acid (PGA) sheets for covering the ESD defect in a randomized controlled trial. Unfortunately the endoscopic "shielding" method did not decrease the rate of post-ESD hemorrhage. The study had an unexpectedly low rate of bleeding in the control arm, which maybe due to the suboptimal inclusion criteria. On the other hand, with recent advances in endoscopic closure methods such as the use of OverStitchTM (Apollo Endosurgery, Inc), loop-clip purse string closure and line-assisted closure, complete closure of post-resection defect (even full thickness defects) is technically feasible. It is unclear whether achieving complete closure of the mucosal defect after gastric ESD could reduce the risk of delayed hemorrhage. Therefore the investigators decided to perform this pilot study to investigate the efficacy of this technique.
The purpose of this study is to investigate the clinical usefulness of endoscopic closure of mucosal defect after gastric ESD in patients at high risk of post-ESD hemorrhage. Technical success, clinical success and the incidence of post-ESD adverse events would be recorded. Comparative study would be conducted with historical control.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospectively collected cohort of 30 patients. Compared with historical cohort.|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Closure of Mucosal Defect After High-risk Gastric Endoscopic Submucosal Dissection (ESD) - a Pilot Study|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Endoscopic closure
Prospectively collected patients for gastric ESD and would undergo closure of defect
Procedure: Endoscopic closure of ESD defect
Closure of ESD defect would be performed with clip loop purse string technique
Historical control of patients who underwent gastric ESD
Other: Gastric ESD without closure of ESD defect
Historical control with patients undergoing ESD without closure of ESD defect
- Technical success rate [ Time Frame: 1 day ]Rate of complete closure of the ESD defect in the index endoscopic resection procedure
- Clinical success rate [ Time Frame: 2 weeks ]A persistent closure of ESD defect during follow-up endoscopy at 2 weeks
- Rate of Post-ESD haemorrhage [ Time Frame: 30 days ]Presence of blood clots in the stomach or the need for endoscopic hemostasis during urgent endoscopy if patient shows signs suspicious of bleeding
- Rate of adverse events of the procedure [ Time Frame: 30 days ]Rate of adverse events related to the procedure, graded according to the CTCAE criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282707
|Contact: Hon Chi Yip, MBChB||+852 firstname.lastname@example.org|
|The Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Hon Chi Yip, MBChB, FRCSEd (Gen) +85235052627 email@example.com|
|Principal Investigator:||Hon Chi Yip, MBChB||Chinese University of Hong Kong|