Clinical trial · Observational
Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Safety and Feasibility Between Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer:A Prospective Cohort Study
NCT03500471CI-TRIAL-00054587completedClinicalTrials.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)
This study is a prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing robotic-assisted total gastrectomy with D2 lymph nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.
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-assisted Total Gastrectomy | Procedure | — | UNRESOLVED |
| Robotic-assisted Total Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Experimental: Robotic surgery
- description
- Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy
- interventionNames
- Procedure: Robotic-assisted Total Gastrectomy
- label
- Compared: Laparoscopic surgery
- description
- Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy
- interventionNames
- Procedure: Laparoscopic-assisted Total Gastrectomy
Primary outcomes (1)
- measure
- Overall postoperative morbidity and mortality
- timeFrame
- 30 days
- description
- Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically proven gastric adenocarcinoma; 2. Age: older than 18 years old, younger than 80 years old; 3. Tumor located in the upper third of the stomach or esophagogastric junction or other location, and is possible to be curatively resected by total gastrectomy; 4. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition; 5. American Society of Anesthesiology (ASA) score of class I to III; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Patients who freely give informed consent to participate in the clinical study; Exclusion Criteria: 1. Early gastric cancer; 2. Age: younger than 18 years old, older than 80 years old; 3. Total gastrectomy with D2 lymphadenectomy was not required; 4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; 5. Emergency surgery for gastric cancer-related complications (bleeding or complete obstruction or perforation); 6. Previous upper abdominal surgery (except laparoscopic cholecystectomy); 7. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer; 8. Unstable angina or myocardial infarction within the past 6 months; 9. Cerebrovascular accident within the past 6 months; 10. American Society of Anesthesiology (ASA) score of class more than III; 11. Severe respiratory disease (FEV1\< 50%); 12. Continuous systemic steroid therapy within 1 month before the study; 13. Pregnant or breast-feeding women;
References
Publications (9)
- BACKGROUNDJapanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available. PMID 27342689
- BACKGROUNDHaverkamp L, Weijs TJ, van der Sluis PC, van der Tweel I, Ruurda JP, van Hillegersberg R. Laparoscopic total gastrectomy versus open total gastrectomy for cancer: a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1509-20. doi: 10.1007/s00464-012-2661-1. Epub 2012 Dec 14. PMID 23263644
- BACKGROUNDEtoh T, Honda M, Kumamaru H, Miyata H, Yoshida K, Kodera Y, Kakeji Y, Inomata M, Konno H, Seto Y, Kitano S, Hiki N. Morbidity and mortality from a propensity score-matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: data from a nationwide web-based database. Surg Endosc. 2018 Jun;32(6):2766-2773. doi: 10.1007/s00464-017-5976-0. Epub 2017 Dec 7. PMID 29218676
- BACKGROUNDYoon HM, Kim YW, Lee JH, Ryu KW, Eom BW, Park JY, Choi IJ, Kim CG, Lee JY, Cho SJ, Rho JY. Robot-assisted total gastrectomy is comparable with laparoscopically assisted total gastrectomy for early gastric cancer. Surg Endosc. 2012 May;26(5):1377-81. doi: 10.1007/s00464-011-2043-0. Epub 2011 Nov 16. PMID 22083338
- BACKGROUNDSon T, Lee JH, Kim YM, Kim HI, Noh SH, Hyung WJ. Robotic spleen-preserving total gastrectomy for gastric cancer: comparison with conventional laparoscopic procedure. Surg Endosc. 2014 Sep;28(9):2606-15. doi: 10.1007/s00464-014-3511-0. Epub 2014 Apr 3. PMID 24695982
- BACKGROUNDShen W, Xi H, Wei B, Cui J, Bian S, Zhang K, Wang N, Huang X, Chen L. Robotic versus laparoscopic gastrectomy for gastric cancer: comparison of short-term surgical outcomes. Surg Endosc. 2016 Feb;30(2):574-580. doi: 10.1007/s00464-015-4241-7. Epub 2015 Jul 25. PMID 26208497