Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Jan 1, 2028 → Jan 31, 2029
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Record History

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  1. Secondary endpoints: 7 to 9
  2. Primary completion pushed from Jan 1, 2028 to Jan 31, 2029 Show 7 more changesShow less
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Study completion pushed from Jan 1, 2029 to Mar 31, 2029
    • Study sites: 1 to 3
    • Eligibility criteria shortened, about 172 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 255 words
    • Study title shortened, about 4 words
  3. Start date: Aug 20, 2026 to Oct 20, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 7 entries
  4. Start date: Jan 1, 2026 to Aug 20, 2026v3
  5. Primary endpoint(s) modified
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 1 to 7
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Gastric outlet obstruction (GOO) complicates locally advanced or metastatic gastric cancer and severely impairs oral intake, nutritional status, and quality of life. Conventional gastrojejunostomy (CGJ) effectively relieves the obstruction but is associated with a high incidence of delayed gastric emptying (DGE), which delays the resumption of oral intake and the initiation of systemic anticancer therapy. Stomach-partitioning gastrojejunostomy (SPGJ) isolates the tumour-bearing distal stomach from the alimentary tract and has been suggested, in retrospective studies, to reduce the incidence of DGE. However, the only randomized comparison reported to date was a small monocentric trial that assessed oral intake acceptance rather than gastric emptying. The comparative effect of SPGJ and CGJ on delayed gastric emptying therefore remains untested in a randomized setting. This multicenter, randomized, open-label, blinded-outcome-assessment trial will randomly assign 80 participants with unresectable distal gastric adenocarcinoma complicated by GOO, in a 1:1 ratio, to undergo either SPGJ or CGJ. The primary endpoint is the incidence of postoperative DGE within 30 days after surgery.
Trial Details
NCT Number NCT07561073
Lead Sponsor Guangxi Medical University
Conditions
(from sponsor)		 Gastric Cancer, Gastric Outlet Obstruction
Related terms Gastric Outlet Obstruction, Gastroparesis, Stomach Neoplasms
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov