Clinical trial NCT01584336: Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
Official title: Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric cancer, laparoscopy-assisted total gastrectomy
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Gastric cancer remains one of the most common neoplasms in Asia and some western countries, although the incidence is decreasing worldwide. Recently,as the rate of detection of early gastric cancer has increased and surgical techniques have been developed, laparoscopic procedures have been introduced and tried for the treatment of early-stage gastric cancer.

Already the prospective, randomized trials for safety and oncologic outcomes of laparoscopy-assisted distal gastrectomy for gastric cancer had been tried, but the large-scaled, prospective study for laparoscopy-assisted total gastrectomy (LATG) is seldom.

One reason for the low popularity is that LATG requires the dissection of lymph nodes at the splenic hilum or along the short gastric arteries and the other reason is that the reconstruction after total gastrectomy is also more complicated. The third reason is that the chance for total gastrectomy is less frequent than distal gastrectomy because of the low incidence of upper gastric cancer.

This KLASS-03 trial is a prospective, multicenter trial for LATG for early upper gastric cancer. The primary purpose of this study is to evaluate the incidence of postoperative morbidity and mortality and the second purpose is to evaluate the surgical outcomes after several methods of reconstruction in laparoscopic total gastrectomy and the postoperative course of LATG patients.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of postoperative morbidity and mortality
timeFrame: 1 month
Secondary outcomes:
measure: the surgical outcomes according to the method of reconstruction
timeFrame: 1 month
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University medical Center
city: Incheon
country: Korea, Republic of
facility: Incheon St, Mary's Hostpial, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Gyu-Seok Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.