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, no randomized evidence is currently available, and the comparative safety and efficacy of SPGJ and CGJ remain uncertain. 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.
Patients and their family members must be fully informed of the study procedures and voluntarily provide written informed consent prior to enrollment.
Age 18-75 years (inclusive).
Pathologically confirmed distal gastric adenocarcinoma deemed unresectable due to locally advanced disease, distant metastasis, or peritoneal dissemination (cT4bM0 or T3-4M1, regardless of the clinical lymph node status, stage IV), and therefore unsuitable for curative resection.
Presence of gastrointestinal obstruction confirmed by upper gastrointestinal contrast radiography or endoscopy, manifested as gastric retention with a Gastric Outlet Obstruction Scoring System (GOOSS) score <= 1.
Inability or unwillingness to comply with the study protocol or required study procedures.
History of another malignancy within 5 years prior to enrollment, with the exception of adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix following curative therapy.
Active autoimmune disease within 4 weeks prior to enrollment or a documented history of autoimmune disease.
Prior allogeneic bone marrow transplantation or solid organ transplantation.
Parallel
stomach-partitioning gastrojejunostomy
Procedure/SurgeryAt the junction of the gastric body and the antrum, or about 5cm from the upper edge of the tumor, a straight-line cutting closure device was used to cut off part of the gastric body from the greater curvature of the stomach to form a partition, and a 2-3cm wide gastric body near the lesser curvature was retained. A hole was made in the greater curvature of the posterior gastric wall at the proximal end of the septum, and a hole was made in the jejunum-to-mesenteric margin 5-10 cm from the Treitz ligament. A linear cutting closure device was placed through the transverse colon. The greater curvature-jejunum side-to-side anastomosis of the posterior gastric wall with pro-peristalsis or anti-peristalsis was performed, and the common opening was closed by using a linear cutting closure device or suture.
conventional gastrojejunostomy
Procedure/SurgeryThe lowest point of the greater curvature of the stomach and the proximal jejunum 5-10 cm away from the Treitz ligament were subjected to side-to-side anastomosis of peristaltic or anti-peristaltic using a linear cutter before the transverse colon, and the common opening was closed using a linear cutter or suture.
Incidence of delayed gastric emptying（DGE）
Delayed gastric emptying (DGE) is defined as impaired progression of oral intake, persistent or recurrent vomiting, abdominal distension, or prolonged or recurrent need for nasogastric tube (NGT) decompression, after mechanical causes (anastomotic stenosis or oedema, intestinal kinking or torsion, afferent or efferent limb obstruction) and other postoperative complications (postoperative ileus, anastomotic leakage, intra-abdominal infection, bleeding, tumour progression) have been considered and excluded where clinically appropriate. Severity is graded according to criteria adapted from the International Study Group of Pancreatic Surgery (ISGPS).
Incidence of early postoperative complications
Proportion of participants experiencing any postoperative complication graded Clavien-Dindo grade II or above, or any adverse event graded CTCAE v5.0 grade 2 or above, within 30 days after surgery.
Nutritional status
Nutritional status assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) score. PG-SGA assessment table contains seven aspects, which are divided into two parts : the patient self-assessment part ( A score ) and the medical staff assessment part ( B + C + D score ). The total score is obtained by adding the two parts.
Incidence of late postoperative complications
Proportion of participants experiencing any postoperative complication occurring from 30 days to 12 months after surgery.
Incidence of anastomotic complications
Proportion of participants experiencing anastomotic leakage, anastomotic stenosis, or anastomotic bleeding.
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Guangxi Medical University
Lead sponsor
Cancer Hospital of Guangxi Medical University
Sponsor institution
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