Clinical trial · Interventional
Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection
Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
NCT02980861CI-TRIAL-00025017unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic total gastrectomy | Procedure | — | UNRESOLVED |
| Open total gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic total gastrectomy
- description
- Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
- interventionNames
- Procedure: Laparoscopic total gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Open total gastrectomy
- description
- Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
- interventionNames
- Procedure: Open total gastrectomy
Primary outcomes (1)
- measure
- Number of group Splenic Hilum (No.10) lymph nodes harvested
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy; 2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition. 3. Eastern Cooperative Oncology Group (ECOG): 0 or 1; 4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ; 5. Written informed consent. Exclusion Criteria: 1. Pregnant or breast-feeding women; 2. Severe mental disorder; 3. Previous upper abdominal surgery (except laparoscopic cholecystectomy); 4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection; 5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; 6. Other malignant disease within the past 5 years; 7. Previous neoadjuvant chemotherapy or radiotherapy; 8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease); 9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
References
Publications (2)
- BACKGROUNDBian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3. PMID 26940944
- DERIVEDGuo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31. PMID 30380145