Clinical trial · Interventional
Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer
A Multicenter Prospective Randomized Double-Blind Clinical Trial Comparing Proximal Gastrectomy and Total Gastrectomy in Patients With Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter prospective randomized clinical trial aims to compare the safety and oncological effectiveness of proximal gastrectomy and total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Eligible patients will be randomly assigned to undergo either proximal gastrectomy or total gastrectomy using open, laparoscopic, or robotic surgical approaches according to clinical suitability. The primary outcome of the study is 3-year disease-free survival. Secondary outcomes include postoperative mortality, postoperative complications, and the number of metastatic lymph nodes retrieved. Patients will be followed for up to five years after surgery to evaluate long-term oncological outcomes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction Cancer | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proximal Gastrectomy | Procedure | — | UNRESOLVED |
| Total Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proximal Gastrectomy
- description
- Patients randomized to this arm will undergo proximal gastrectomy with D2 lymphadenectomy. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.
- interventionNames
- Procedure: Proximal Gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Total Gastrectomy
- description
- Patients randomized to this arm will undergo total gastrectomy with D2 lymphadenectomy. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.
- interventionNames
- Procedure: Total Gastrectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 90 years * Histologically confirmed locally advanced Siewert type II-III gastroesophageal junction cancer * Considered operable after multidisciplinary tumor board evaluation * Candidate for curative surgical resection with D2 lymphadenectomy * Provision of written informed consent Exclusion Criteria: * Early-stage gastroesophageal junction cancer * Gastric cancers located in the antrum or corpus * Severe anesthetic risk (American Society of Anesthesiologists \[ASA\] class IV or higher) * Pregnancy * Patients unwilling or unable to provide informed consent
References
Publications (2)
- RESULTZhu G, Jiao X, Zhou S, Zhu Q, Yu L, Sun Q, Li B, Fu H, Huang J, Lang W, Lang X, Zhai S, Xiong J, Fu Y, Liu C, Qu J. Can proximal gastrectomy with double-tract reconstruction replace total gastrectomy? a meta-analysis of randomized controlled trials and propensity score-matched studies. BMC Gastroenterol. 2024 Jul 23;24(1):230. doi: 10.1186/s12876-024-03323-7. PMID 39044132
- RESULTYang X, Zeng Z, Liao Z, Zhu C, Wang H, Wu H, Cao S, Liang W, Li X. Comparison of proximal gastrectomy and total gastrectomy in proximal gastric cancer: a meta-analysis of postoperative health condition using the PGSAS-45. BMC Cancer. 2024 Oct 15;24(1):1282. doi: 10.1186/s12885-024-13046-3. PMID 39407137