Clinical trial · Interventional
Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer
Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer
NCT02464215CI-TRIAL-00045068SWEETunknownN/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)
The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced 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 surgery | Procedure | — | UNRESOLVED |
| open surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- open surgery
- description
- Conventional procedure,Open surgery
- interventionNames
- Procedure: open surgery
- type
- EXPERIMENTAL
- label
- laparoscopic surgery
- description
- Minimum invasive procedure,Laparoscopic surgery
- interventionNames
- Procedure: laparoscopic surgery
Primary outcomes (1)
- measure
- Postoperative complication rate
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: older than 18 years old,including 18 years old 2. Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma) 3. Cancer core: located at lower part of stomach 4. Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging) 5. surgery:subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection 6. ASA score: ≤ 3;ECOG performance status 0/1 7. Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) Exclusion Criteria: 1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient 2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy 3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy) 4. Patient who was treated because of systemic inflammatory disease 5. Pregnant patient or lactating women 6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis 7. serious mental illness 8. gastric surgery (including for gastric ESD / EMR) 9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm) 10. other malignant diseases in 5 years 11. have unstable angina or myocardial infarction within six months 12. have cerebral infarction or cerebral hemorrhage within 6 months 13. sustained systemic glucocorticoid treatment history within 1 month 14. have other diseases needed operative treatment at the same time 15. complications (bleeding, perforation, obstruction) required emergency surgery 16. Pulmonary function tests FEV1 \<50% of predicted value.
References
Publications (2)
- DERIVEDXing J, Cai J, Wang X, Zhang N, An D, Li F, Cui M, Niu L, Gao C, Fan Q, Ren S, Zhang Z, Su X; SWEET trial group. Long-term outcomes of laparoscopic versus open distal gastrectomy for patients with advanced gastric cancer in North China: a multicenter randomized controlled trial. Surg Endosc. 2024 Sep;38(9):4976-4985. doi: 10.1007/s00464-024-10952-2. Epub 2024 Jul 9. PMID 38981881
- DERIVEDWang Z, Xing J, Cai J, Zhang Z, Li F, Zhang N, Wu J, Cui M, Liu Y, Chen L, Yang H, Zheng Z, Wang X, Gao C, Wang Z, Fan Q, Zhu Y, Ren S, Zhang C, Liu M, Ji J, Su X. Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial. Surg Endosc. 2019 Jan;33(1):33-45. doi: 10.1007/s00464-018-6391-x. Epub 2018 Nov 1. PMID 30386984