Endoscopic relief from gastric outlet obstruction

Not yet recruiting

Conditions: Neoplasms,

Registration Number: CTRI/2021/10/037017

Lead Sponsor: SL Raheja Hospital

Brief Summary: Background:EUS-guidedballoon-occluded gastrojejunostomy bypass (EPASS) is an emerging technique formanagement of malignant gastric outlet obstruction. However, how the modalitycompares to conventional duodenal stenting is uncertain.

Aims andhypothesis:Theaim of the current study is to compare the efficacy of EPASS versus uncoveredpyloro-duodenal stents (DS) in unresectable malignant gastric outletobstruction. We hypothesize that EPASS could reduce the re-intervention rateswhen compared to DS

Methods

Thiswould be a prospective multi-centered randomized controlled study, comparingthe use of EPASS versus DS in patients suffering unresectable malignant gastricoutlet obstruction. Consecutive patients with confirmed unresectablegastro-duodenal or pancreatico-biliary malignancies causing gastric outlet obstructionwould be included. The primary outcome measurement is the 6-monthre-intervention rate. Secondary outcomes include technical and clinicalsuccess, adverse events rate, mortality, pre- and post stenting gastric outletobstruction scores (GOOS), causes of stent dysfunction, the duration of stentpatency, cost and quality of life assessment scores.

Analysis

All outcomes would be analyzed according to the intention-to-treatprinciple. Comparisons would be made by Chi-square test or Fisherexact test for categorical data, Mann-Whitney U for non-parametric continuousdata. Cumulative stent patency and patient survival times are analyzed usingthe Kaplanâ€“Meier method and compared using the log-rank test.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 92

Inclusion Criteria

All patients with unresectable malignant gastric outlet obstruction will be included in the study.
Valid consent.

Exclusion Criteria

Coagulopathy Significant ascites no valid consent Benign tumours Neoadjuvant chemotherapy for current malignancy Patients for whom endoscopic techniques are contraindicated Participation in another investigational trial within 180 days Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in symptoms from gastric outlet obstruction. GOO score calculator	GOO score on Day 1, 3. \| Week 1, 4, 12, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Long term stent patency	1, 3, 6,12 months

Trial Locations

Locations (1): SL Raheja Hospital
🇮🇳
(Suburban), MAHARASHTRA, India
SL Raheja Hospital
🇮🇳(Suburban), MAHARASHTRA, India
RAHUL SHAH
Principal investigator
9820190508
rahulhshah@hotmail.com