Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)

NCT01584336 | Unknown Phase 2 DMC

• 1 other identifier: KLASS-03
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 10

Brief Summary

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

Gastric Cancer

Keywords

Gastric cancer, laparoscopy-assisted total gastrectomy

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative morbidity and mortality

  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.

  1 month

Secondary Outcomes (1)

• the surgical outcomes according to the method of reconstruction

  1 month

Study Arms (1)

LATG group

EXPERIMENTAL

It means the patients who will be enrolled in our study.

Procedure: LATG

Interventions

LATG PROCEDURE

1. After laparoscopic observation, the surgeon must check the possibility of laparoscopic surgery (without the serosal invasion of cancer or peritoneal metastasis or lymph node metastasis to splenic hilum). If the gastric cancer with serosal invasion or grossly lymph node metastasis to splenic hilum, operator must convert the operation method to open gastrectomy 2. The operator undergoes the laparoscopic total gastrectomy with lymph node dissection(including the status of lymph nodes - No #1,2,3,4sa,4sb,4d,5,6,7,8a,9,11p and 11d, and/or 12a). 3. The operator can choose any reconstruction method of esophagojejunostomy according to surgeon's preference. 4. After then, the operator performs the jejunojejunostomy.

Also known as: Laparoscopy-assisted total gastrectomy (LATG)

LATG group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (10)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, 443-749, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

RECRUITING

Kyungpook National University medical Center

Daegu, 702-210, South Korea

RECRUITING

Incheon St, Mary's Hostpial, The Catholic University of Korea

Incheon, 403-720, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-799, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-799, South Korea

RECRUITING

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (10)

• Kim 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 BACKGROUND

• Kunisaki 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 BACKGROUND

• Nunobe 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 BACKGROUND

• Okabe 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 BACKGROUND

• Kim 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 RESULT

• Kanagale 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 RESULT

• Mochiki 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.

  PMID: 18594925 RESULT

• Kawamura H, Yokota R, Homma S, Kondo Y. Comparison of invasiveness between laparoscopy-assisted total gastrectomy and open total gastrectomy. World J Surg. 2009 Nov;33(11):2389-95. doi: 10.1007/s00268-009-0208-y.

  PMID: 19760315 RESULT

• Tanimura S, Higashino M, Fukunaga Y, Takemura M, Tanaka Y, Fujiwara Y, Osugi H. Laparoscopic gastrectomy for gastric cancer: experience with more than 600 cases. Surg Endosc. 2008 May;22(5):1161-4. doi: 10.1007/s00464-008-9786-2. Epub 2008 Mar 6.

  PMID: 18322744 RESULT

• Lee SE, Ryu KW, Nam BH, Lee JH, Kim YW, Yu JS, Cho SJ, Lee JY, Kim CG, Choi IJ, Kook MC, Park SR, Kim MJ, Lee JS. Technical feasibility and safety of laparoscopy-assisted total gastrectomy in gastric cancer: a comparative study with laparoscopy-assisted distal gastrectomy. J Surg Oncol. 2009 Oct 1;100(5):392-5. doi: 10.1002/jso.21345.

  PMID: 19598150 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Gyu-Seok Cho, M.D., Ph.D.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gyu-Seok Cho, M.D., Ph.D.

CONTACT

+82-32-621-5248; gschogs@schmc.ac.kr

Gui-Ae Jeong, M.D., Ph.D.

CONTACT

+82-621-5254; gwsdlove@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Soonchunhyang University Bucheon Hospital

Study Record Dates

• First Submitted: April 22, 2012
• First Posted: April 24, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 6, 2014

Record last verified: 2014-02

Locations

KR (10)