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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
Sponsor:
Information provided by (Responsible Party):
Hon Chi Yip, Chinese University of Hong Kong

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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospectively collected cohort of 30 patients. Compared with historical cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. Technical success rate [ Time Frame: 1 day ]
    Rate of complete closure of the ESD defect in the index endoscopic resection procedure


Secondary Outcome Measures :
  1. Clinical success rate [ Time Frame: 2 weeks ]
    A persistent closure of ESD defect during follow-up endoscopy at 2 weeks

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing elective gastric endoscopic submucosal dissection for epithelial lesions
  2. Procedure deemed at high risk of post-procedural hemorrhage due to the following:

    1. End stage renal disease (Estimated GFR <15ml/min)
    2. Patients on anti-thrombotic agents (Double antiplatelet, warfarin or direct oral anticoagulants)
    3. Post ESD mucosal defect size >4cm
  3. Target subjects receiving sufficient briefing from the attending physician regarding the content of this study and providing informed consent for participation
  4. Over 20 years of age

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Hon Chi Yip, MBChB +852 35052627 hcyip@surgery.cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Hon Chi Yip, MBChB, FRCSEd (Gen)    +85235052627    hcyip@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Hon Chi Yip, MBChB Chinese University of Hong Kong
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Responsible Party: Hon Chi Yip, Associate consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04282707    
Other Study ID Numbers: CRE-2019.561
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hon Chi Yip, Chinese University of Hong Kong:
Endoscopic submucosal dissection, defect closure
Additional relevant MeSH terms:
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Carcinoma in Situ
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type