Clinical trial · Interventional
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer: A Prospective Trial (FUGES-004)
NCT02792881CI-TRIAL-00069796unknownN/AClinicalTrials.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 aims to investigate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant 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 |
|---|---|---|---|
| Remnant Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic completion total gastrectomy with D2 lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laparoscopic Completion Total Gastrectomy Group
- description
- Patients who underwent laparoscopic completion total gastrectomy with D2 lymphadenectomy will be assigned to this group.
- interventionNames
- Procedure: Laparoscopic completion total gastrectomy with D2 lymphadenectomy
Primary outcomes (1)
- measure
- Morbidity
- timeFrame
- 30 days
- description
- The early postoperative complication are defined as the event observed within 30 days after surgery.
Secondary outcomes (14)
- measure
- 3-year disease free survival rate
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Age between 18 and 75 years; Carcinomas arise in the remnant stomach following gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or the method of reconstruction; cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 7th Edition; Performance status of 0 or 1 on ECOG scale; ASA class I, II, or III; Written informed consent. Exclusion Criteria: Distant metastasis in the preoperative examinations; Previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection); Other malignant diseases (except gastric cancer) within the past 5 years; Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes; Women during breast-feeding or pregnancy; Severe mental disorder; Unstable myocardial infarction, angina, or cerebrovascular accident within the past 6 months; History of continuous systematic administration of corticosteroids within one month; FEV1\<50% of predicted values; Requirement of simultaneous surgery for other disease; Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer.
References
Publications (2)
- DERIVEDWu D, Zhong Q, Zhang ZQ, Liu SQ, Qiu TY, Chen JY, Jiang YM, Lin GT, Liu ZY, Shang-Guan ZX, Sun YQ, Zheng CH, Li P, Xie JW, Lin JX, Chen QY, Huang CM. Comprehensive comparison of technical performance, surgical outcomes, and oncologic prognosis between remnant gastric cancer and primary upper-third gastric cancer in the era of minimally invasive surgery: A pooled analysis of 3 prospective trials. Surgery. 2025 Jul;183:109395. doi: 10.1016/j.surg.2025.109395. Epub 2025 May 8. PMID 40344992
- DERIVEDZhong Q, Wu D, Jiang YM, He QL, Dang XY, Xu DB, Sun YQ, Su GQ, Guo KQ, Cai LS, Zhang HX, Ye W, Lin GT, Li P, Xie JW, Chen QY, Zheng CH, Lu J, Huang CM, Lin JX. The safety, feasibility, and oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer: a prospective study with 3-year follow-up (FUGES-004 study). Int J Surg. 2024 Jun 1;110(6):3382-3391. doi: 10.1097/JS9.0000000000001388. PMID 38597388