Clinical trial · Interventional
Clinical Trial for Laparoscopic D2 Gastrectomy
A Phase-II Clinical Trial of Laparoscopy-Assisted Distal Gastrectomy With D2 Lymph Node Dissection for Gastric 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)
Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective surgical option. Methods: total 64 patients, who are diagnosed preoperatively as having T1-2, N0-1 or M0 gastric cancer, will be prospectively enrolled to undergo LADG with D2 lymph node dissection; two surgeons with experience of over 50 cases of laparoscopic gastrectomy performed the procedures. The compliance rate, defined as cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping, for the open gastrectomy with D2 lymph node dissection was 66.0% in a pilot study and was used for calculations of sample size. Compliance rate and other surgical outcomes, including the number of retrieved lymph nodes from each lymph node station, morbidities, mortalities and conversion rate will be analyzed.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic D2 distal gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laparoscopic D2 gastrectomy
- interventionNames
- Procedure: Laparoscopic D2 distal gastrectomy
Primary outcomes (1)
- measure
- Compliance of lymph node dissection
- timeFrame
- immediate postoperative 1 week
- description
- noncompliance : if two or more nodal station is vacant, it is a noncompliant D2 gastrectomy.
Secondary outcomes (9)
- measure
- Proportion of patients with retrieved lymph nodes less than 26
- timeFrame
- Postoperative 1 week
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the stomach, * Age between 18 and 75 years, performance status of ECOG 0-1 * Signed informed consent * Location of the primary tumor in the antrum, angle and lower body * No evidence of distant metastasis or invasion to adjacent organs or serosal infiltration, * Enlarged lymph node size 2 cm or less on CT and no conglomerate nodes or regional * Lymph node metastasis confined to perigastric nodes (N1) as shown on by CT and EUS Exclusion Criteria: * Metastatic disease, previous history of malignancy in any organ, any co-morbidity * Obviating major surgery, contraindication to laparoscopy such as severe cardiac disease * Abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy, previous upper abdominal surgery, complicated cases requiring emergency surgery, and an accompanying surgical condition requiring surgery at the same time
References
Publications (3)
- BACKGROUNDRyu KW, Kim YW, Lee JH, Nam BH, Kook MC, Choi IJ, Bae JM. Surgical complications and the risk factors of laparoscopy-assisted distal gastrectomy in early gastric cancer. Ann Surg Oncol. 2008 Jun;15(6):1625-31. doi: 10.1245/s10434-008-9845-x. Epub 2008 Mar 14. PMID 18340493
- RESULTLee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20. PMID 17705092
- RESULTLee SE, Kim YW, Lee JH, Ryu KW, Cho SJ, Lee JY, Kim CG, Choi IJ, Kook MC, Nam BH, Park SR, Kim MJ, Lee JS. Developing an institutional protocol guideline for laparoscopy-assisted distal gastrectomy. Ann Surg Oncol. 2009 Aug;16(8):2231-6. doi: 10.1245/s10434-009-0490-9. Epub 2009 May 9. PMID 19430842