Gastric CancerNCT07561073
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
A study testing stomach-partitioning gastrojejunostomy and conventional gastrojejunostomy in people with Gastric Cancer and Gastric Outlet Obstruction, run by Guangxi Medical University at 3 sites in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastric Outlet Obstruction
- What is being tested?
- stomach-partitioning gastrojejunostomy and conventional gastrojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesChina
- Study dates
- 20 Oct 2026to 31 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 without deterioration within 7 days prior to enrollment.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- No prior antitumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Who cannot join
- 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.
- Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe or unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure classified as New York Heart Association (NYHA) functional class > II; ventricular arrhythmias requiring pharmacologic treatment; or left ventricular ejection fraction (LVEF) < 50%.
- Active or uncontrolled severe infection, defined as grade >= 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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- Known human immunodeficiency virus (HIV) infection, or a history of clinically significant liver disease, including viral hepatitis: known hepatitis B virus (HBV) carriers must be excluded if active HBV infection is present, defined as HBV DNA positivity (> 1 x 10^4 copies/mL or > 2000 IU/mL); known hepatitis C virus (HCV) infection with positive HCV RNA (> 1 x 10^3 copies/mL).
- Pregnant women (positive pregnancy test prior to treatment initiation) or lactating women.
- Any other disease, clinically significant metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the judgment of the investigator, may render the patient unsuitable for study participation (e.g., uncontrolled seizure disorder requiring treatment), interfere with the interpretation of study results, or place the patient at undue risk.
- Any condition that, in the opinion of the investigator, makes the patient inappropriate for inclusion in this trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Yuzhou Qin, Ph.D, +867715310421, qyz402@126.com
Liucheng Wu, Ph.D, 13737146973, wuliucheng@gxmu.edu.cn
Wuming Hospital of Guangxi Medical University
Nanning, State..., 530021
0771-6222411, gxmuwmfy@163.com
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002
0774-3827268, hhyyoffice@163.com
About this study
Official title: A Multicenter Randomized Controlled Trial Comparing the Safety and Efficacy of Stomach-Partitioning Gastrojejunostomy (SPGJ) Versus Conventional Gastrojejunostomy (CGJ) for Advanced Gastric Cancer-Associated Gastric Outlet Obstruction
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.
Read the detailed description
This is a prospective, multicenter, randomized, open-label superiority trial with blinded outcome assessment, conducted at three tertiary referral hospitals in Guangxi, China (Guangxi Medical University Cancer Hospital, Wuzhou Red Cross Hospital, and Guangxi Medical University Wuming Hospital). The coordinating center is Guangxi Medical University Cancer Hospital.
Eligible participants will be randomly assigned in a 1:1 ratio to undergo either stomach-partitioning gastrojejunostomy (SPGJ) or conventional gastrojejunostomy (CGJ), using a computer-generated allocation sequence with variable block sizes, stratified by participating centre. The allocation sequence will be generated centrally by an independent statistician and implemented through a centralized, password-protected randomization system. Allocation will remain concealed until eligibility has been confirmed and written informed consent has been obtained.
Surgical procedures cannot be blinded. Outcome assessors (including the radiologist assessing the primary endpoint), research staff collecting patient-reported outcomes, and the statistician performing the prespecified analyses will be blinded to treatment allocation.
In both groups, a laparoscopic approach will be preferred and routine diagnostic laparoscopy will be performed to confirm surgical eligibility. Gastrointestinal reconstruction will use a standardized isoperistaltic configuration; Braun enteroenterostomy and Roux-en-Y reconstruction will not be performed.
In the SPGJ group, partial gastric transection will be performed using a linear cutting stapler, beginning at the greater curvature, at the junction of the gastric body and antrum or approximately 5 cm proximal to the superior margin of the tumour, preserving a 2-3 cm-wide gastric channel along the lesser curvature. A side-to-side gastrojejunostomy will be constructed between the posterior wall of the proximal gastric segment at the greater curvature and the antimesenteric border of the jejunum 5-10 cm distal to the ligament of Treitz, via an antecolic route. The common enterotomy will be closed with a linear stapler or hand-sewn sutures.
In the CGJ group, a side-to-side gastrojejunostomy will be constructed via an antecolic route between the most dependent portion of the greater curvature of the stomach and the proximal jejunum 5-10 cm distal to the ligament of Treitz. The common enterotomy will be closed with a linear stapler or hand-sewn sutures.
Both groups will receive a standardized perioperative management protocol. Participants will be assessed daily for DGE-related signs from postoperative day (POD) 1 to POD 7, with formal DGE assessments on POD 3, 7, 14 and 21, and a further assessment at the 30-day postoperative visit. After the 30-day safety visit, follow-up will be performed every 3 months. A prespecified analysis of overall survival will be performed at 12 months after surgery.
- Conditions
- Gastric Cancer, Gastric Outlet Obstruction
- Being tested
- stomach-partitioning gastrojejunostomy, conventional gastrojejunostomy
- Keywords
- Gastric cancer, conventional gastrojejunostomy, gastric outlet obstruction, stomach-partitioning gastrojejunostomy, delayed gastric emptying, randomized controlled trial
- Medical subject headings
- Stomach Neoplasms, Gastric Outlet Obstruction, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stomach-partitioning gastrojejunostomyProcedure or surgery
Also called Conventional gastrojejunostomy
At 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 gastrojejunostomyProcedure or surgery
The 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.
| Study group | Role | What they receive |
|---|---|---|
| stomach-partitioning gastrojejunostomy (SPGJ) | Experimental | Participants undergo laparoscopic stomach-partitioning gastrojejunostomy. The gastric body is partially transected with a linear cutting stapler, beginning at the greater curvature, at the junction of the gastric body and antrum or approximately 5 cm proximal to the superior margin of the tumour, preserving a 2-3 cm-wide gastric channel along the lesser curvature. A side-to-side gastrojejunostomy is constructed between the posterior wall of the proximal gastric segment and the antimesenteric border of the jejunum 5-10 cm distal to the ligament of Treitz, via an antecolic route, in an isoperistaltic orientation. The common enterotomy is closed with a linear stapler or hand-sewn sutures. Receives: Procedure: stomach-partitioning gastrojejunostomy |
| conventional gastrojejunostomy (CGJ) | Active comparator | Participants undergo laparoscopic conventional gastrojejunostomy. A side-to-side anastomosis is constructed via an antecolic route between the most dependent portion of the greater curvature of the stomach and the proximal jejunum 5-10 cm distal to the ligament of Treitz, in an isoperistaltic orientation. The common enterotomy is closed with a linear stapler or hand-sewn sutures. Receives: Procedure: conventional gastrojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 30 days after surgery
Secondary outcomes (9)
Time to postoperative gastrointestinal functional recovery
Time from surgery to the first occurrence of both passage of flatus and tolerance of a semi-liquid diet without vomiting or need for nasogastric tube decompression.
Measured: 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.
Measured: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy
Health-related quality of life
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the gastric cancer-specific module QLQ-STO22. Scores are standardised to a 0-100 scale.
Measured: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy
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.
Measured: Within 30 days after surgery
Incidence of late postoperative complications
Proportion of participants experiencing any postoperative complication occurring from 30 days to 12 months after surgery.
Measured: From 30 days to 12 months after surgery
Incidence of anastomotic complications
Proportion of participants experiencing anastomotic leakage, anastomotic stenosis, or anastomotic bleeding.
Measured: Within 12 months after surgery
Postoperative mortality
Proportion of participants who die from any cause within 30 days and within 90 days after surgery.
Measured: 30 days and 90 days after surgery
Initiation of subsequent systemic therapy
Proportion of participants initiating systemic anticancer therapy after surgery, and time from surgery to initiation.
Measured: Within 12 months after surgery
Overall survival (OS)
Overall survival, defined as the time from surgery to death from any cause; participants alive at the prespecified analysis time point are censored at the date of last follow-up.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel surgical arms: stomach-partitioning gastrojejunostomy (SPGJ) or conventional gastrojejunostomy (CGJ). Randomization is stratified by participating centre using variable block sizes, with central allocation concealment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Liucheng, Cancer Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561073
- Sponsor's protocol ID
- GXMUCH-G00-2026
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication may be made available by the corresponding author upon reasonable request. Requests will be subject to approval by the principal investigator and the institutional ethics committee, compliance with applicable institutional and regulatory requirements, and execution of a data-sharing agreement.
Publications
Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (GO-PART Study, KLASS 16)