Spots Global Cancer Trial Database for Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy
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Trial Identification
Brief Title: Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy
Official Title: Multicenter Prospective Randomized Controlled Trial of Comparing Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy for Upper Third Early Gastric Cancer (KLASS-05)
Study ID: NCT02892643
Conditions
Study Description
Brief Summary: Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Detailed Description: Participating Surgeons Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated. Patients Registration It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms. After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Bundang Hospital Medical Research Collaborating Center. Each group 69 patients, total 138 subjects will be enrolled. Randomization The registration randomization should be done with 1:1 ratio for each researcher. Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table. Procedure Operations are performed according to the allocated group.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Soonchunhyang University Bucheon Hospital, Bucheon, , Korea, Republic of
Dong-A University Hospital, Busan, , Korea, Republic of
Dankook University Hospital, Cheonan, , Korea, Republic of
Keimyung University Hospital, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Eulji University Hospital, Deajon, Daejeon, , Korea, Republic of
Chonnam National University Hospital, Hwasun, , Korea, Republic of
National Cancer Center, Ilsan, , Korea, Republic of
Pusan National University Hospital, Pusan, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Ewha Womans University Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Yeouido St. Mary's Hospital, Seoul, , Korea, Republic of
Yonsei University Severance Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Contact Details
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