Clinical trial · Interventional
Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy
Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
NCT01804998CI-TRIAL-00056533completedN/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)
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. For last two years, multicenter quality control study (Phase II) has been performed in Korea and tolerable results were observed. Based on these results, multicenter phase III trial is required to validate the clinical role of laparoscopic sentinel lymph node biopsy.
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 |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Sentinel Node Biopsy | Procedure | — | UNRESOLVED |
| Laparoscopy Assisted Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic Sentinel Node Biopsy
- description
- Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in this arm
- interventionNames
- Procedure: Laparoscopic Sentinel Node Biopsy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopy Assisted Gastrectomy
- description
- Conventional procedure is laparoscopy assisted gastrectomy in early gastric cancer patient.
- interventionNames
- Procedure: Laparoscopy Assisted Gastrectomy
Primary outcomes (1)
- measure
- 3 year disease free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * single lesion of adenocarcinoma in preoperative endoscopic biopsy * clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography * tumor size: less than 3cm * location: 2cm far from the pylorus or cardia * aged 20 to 80 * ECOG 0 or 1 * patient who signed the agreement * patient who is suspected to underwent laparoscopy assisted gastrectomy Exclusion Criteria: * indication of endoscopic submucosal resection * inoperable due to poor cardiac, pulmonary function * pregnant * having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen * diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
References
Publications (4)
- DERIVEDEom BW, Yoon HM, Kim YW, Min JS, An JY, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kook MC, Han M, Nam BH, Ryu KW; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial. JAMA Surg. 2024 Aug 1;159(8):900-908. doi: 10.1001/jamasurg.2024.1210. PMID 38809537
- DERIVEDKim YW, Min JS, Yoon HM, An JY, Eom BW, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kook MC, Han M, Nam BH, Ryu KW. Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients With Early Gastric Cancer: A Randomized Clinical Trial. J Clin Oncol. 2022 Jul 20;40(21):2342-2351. doi: 10.1200/JCO.21.02242. Epub 2022 Mar 24. PMID 35324317
- DERIVEDAn JY, Min JS, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kim YW, Yoon HM, Eom BW, Kook MC, Han MR, Nam BH, Ryu KW; SEntinel Node ORIented Tailored Approach (SENORITA) Study Group. Laparoscopic sentinel node navigation surgery versus laparoscopic gastrectomy with lymph node dissection for early gastric cancer: short-term outcomes of a multicentre randomized controlled trial (SENORITA). Br J Surg. 2020 Oct;107(11):1429-1439. doi: 10.1002/bjs.11655. Epub 2020 Jun 3. PMID 32492186
- DERIVEDPark JY, Kim YW, Ryu KW, Nam BH, Lee YJ, Jeong SH, Park JH, Hur H, Han SU, Min JS, An JY, Hyung WJ, Cho GS, Jeong GA, Jeong O, Park YK, Jung MR, Yoon HM, Eom BW. Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol. BMC Cancer. 2016 May 31;16:340. doi: 10.1186/s12885-016-2336-8. PMID 27246120