Clinical trial · Interventional
Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
NCT01584336CI-TRIAL-00013678KLASS-03unknownPhase 2ClinicalTrials.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 safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This study will performed via prospective, multicenter design.
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 |
|---|---|---|---|
| LATG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LATG group
- description
- It means the patients who will be enrolled in our study.
- interventionNames
- Procedure: LATG
Primary outcomes (1)
- measure
- The incidence of postoperative morbidity and mortality
- timeFrame
- 1 month
- description
- The primary purpose of this study is that the incidence of morbidity and mortality after LATG. We will access the postoperative morbidity including as follows: wound complication, intra-abdominal fluid collection or abscess, intra-abdominal bleeding, intraluminal bleeding, intestinal obstruction, ileus, anastomotic stenosis, anastomotic leakage, fistula, pancreatitis, pulmonary complication, urinary complication, renal complication, hepatic complication, cardiac complication, endocrine complication, and stasis. Also we will evaluate the incidence of postoperative mortality after LATG.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy * range of age ; over 20 years to under 80 years * preoperative stage : cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC) * The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction * the gastric cancer which is not included the indication of the endoscopic mucosal dissection * ECOG (Eastern Cooperative Oncology Group) performance status; 0 and 1 * ASA (American Society of Anesthesiology) score ; 1, 2, 3 * Written informed consent Exclusion Criteria: * The patient who shows distant metastasis under preoperative examination * The patient with medical history for upper abdominal surgery with open method in the past * The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past(remnant stomach cancer) * The patient with double cancer synchronous or metachronous within 5 years * Enlarged lymph nodes of the splenic hilum in the preoperative evaluation * The patient who has been enrolled other clinical study within 6 months * Vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy
References
Publications (10)
- BACKGROUNDKim SG, Lee YJ, Ha WS, Jung EJ, Ju YT, Jeong CY, Hong SC, Choi SK, Park ST, Bae K. LATG with extracorporeal esophagojejunostomy: is this minimal invasive surgery for gastric cancer? J Laparoendosc Adv Surg Tech A. 2008 Aug;18(4):572-8. doi: 10.1089/lap.2007.0106. PMID 18721007
- BACKGROUNDKunisaki C, Makino H, Oshima T, Fujii S, Kimura J, Takagawa R, Kosaka T, Akiyama H, Morita S, Endo I. Application of the transorally inserted anvil (OrVil) after laparoscopy-assisted total gastrectomy. Surg Endosc. 2011 Apr;25(4):1300-5. doi: 10.1007/s00464-010-1367-5. Epub 2010 Oct 17. PMID 20953884
- BACKGROUNDNunobe S, Hiki N, Tanimura S, Kubota T, Kumagai K, Sano T, Yamaguchi T. Three-step esophagojejunal anastomosis with atraumatic anvil insertion technique after laparoscopic total gastrectomy. J Gastrointest Surg. 2011 Sep;15(9):1520-5. doi: 10.1007/s11605-011-1489-7. Epub 2011 May 10. PMID 21557017
- BACKGROUNDOkabe H, Obama K, Tanaka E, Nomura A, Kawamura J, Nagayama S, Itami A, Watanabe G, Kanaya S, Sakai Y. Intracorporeal esophagojejunal anastomosis after laparoscopic total gastrectomy for patients with gastric cancer. Surg Endosc. 2009 Sep;23(9):2167-71. doi: 10.1007/s00464-008-9987-8. Epub 2008 Jun 14. PMID 18553203
- RESULTKim MG, Kim BS, Kim TH, Kim KC, Yook JH, Kim BS. The effects of laparoscopic assisted total gastrectomy on surgical outcomes in the treatment of gastric cancer. J Korean Surg Soc. 2011 Apr;80(4):245-50. doi: 10.4174/jkss.2011.80.4.245. Epub 2011 Apr 12. PMID 22066043
- RESULTKanagale P, Lohray BB, Misra A, Davadra P, Kini R. Formulation and optimization of porous osmotic pump-based controlled release system of oxybutynin. AAPS PharmSciTech. 2007 Jul 13;8(3):E53. doi: 10.1208/pt0803053. PMID 17915803
- RESULTMochiki E, Toyomasu Y, Ogata K, Andoh H, Ohno T, Aihara R, Asao T, Kuwano H. Laparoscopically assisted total gastrectomy with lymph node dissection for upper and middle gastric cancer. Surg Endosc. 2008 Sep;22(9):1997-2002. doi: 10.1007/s00464-008-0015-9. Epub 2008 Jul 2.