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A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol).

ABSTRACT: BACKGROUND:KLASS (the Korean Laparoendoscopic Gastrointestinal Surgery Study) is a time-honored study group that has established laparoscopic surgery for gastrointestinal disease in Korea and has performed some important studies for the rationale of laparoscopic gastrointestinal surgery. A multi-center RCT (randomized controlled trial) to compare the quality of life (QOL) of patients undergoing totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer, named as KLASS 07, has been currently prepared in Korea. METHODS:Patients diagnosed as gastric cancer, with clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the Americal Joint Committee on Cancer System, were randomized to receive either TLDG or LADG. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 gastrectomies and at least 30 gastrectomies annually (regardless of open or laparoscopic surgery for gastric cancer). The patients who are allocated to TLDG group undergo intracorporeal anastomosis and those who are assigned to LADG undergo extracorporeal anastomosis for gastrointestinal reconstruction. DISCUSSION:Thirty-one surgeons from 26 institutions were engaged in this trial. The primary endpoint is 30-day morbidity, and secondary endpoint is QOL assessed by the questionnaire score. The KLASS 07 trial is the first multi-center RCT to investigate whether there are significant and quantifiable differences between the QOL of TLDG and LADG. The findings from this trial are expected to be the critical clues for designing the detailed procedures during laparoscopic surgery for gastric cancer. TRIAL REGISTRATION:The protocol of KLASS 07 (CKLASS 01) was registered in http://register.clinicaltrials.gov as NCT03393182 (Date of registration: January 2nd, 2018.).

SUBMITTER: Lee CM

PROVIDER: S-EPMC6407283 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol).

Lee Chang Min CM Park Ji Ho JH In Choi Chang C Lee Han Hong HH Min Jae-Seok JS Jee Ye Seob YS Jeong Oh O Chae Hyundong H Choi Sung Il SI Huang Hua H Park Sungsoo S

BMC cancer 20190307 1

<h4>Background</h4>KLASS (the Korean Laparoendoscopic Gastrointestinal Surgery Study) is a time-honored study group that has established laparoscopic surgery for gastrointestinal disease in Korea and has performed some important studies for the rationale of laparoscopic gastrointestinal surgery. A multi-center RCT (randomized controlled trial) to compare the quality of life (QOL) of patients undergoing totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LA ...[more]

PMID: 30845995

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Project description:IntroductionLaparoscopic distal gastrectomy (LDG) is regarded as a standard treatment for patients with clinical stage I-III gastric cancer. With the popularisation of the Da Vinci robotic system in the 21st century, robotic distal gastrectomy has been increasingly applied, and its potential advantages over LDG have been proved by several studies. Intraperitoneal anastomosis is a hot topic in research as it highlights the superiority of minimally invasive surgery and is safe and feasible. We intend to conduct this randomised clinical trial to focus on short-term outcomes and quality of life (QOL) in totally laparoscopic distal gastrectomy (TLDG) and totally robotic distal gastrectomy (TRDG) for patients with clinical stage I-III gastric cancer.Methods and analysisThis study is a prospective, multi-institutional, open-label randomised clinical trial that will recruit 722 patients with a 1:1 ratio (361 patients in the TLDG group and 361 patients in the TRDG group) from eight large-scale gastrointestinal medical centres in China. The primary endpoint is 30-day postoperative morbidity. The secondary endpoints include QOL, 30-day severe postoperative morbidity and mortality, anastomotic-related complication rate, conversion to open surgery rate, intraoperative and postoperative indicators, operative and total costs during hospitalisation, 1-year overall survival and disease-free survival. QOL is determined by the The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 and Stomach22 (EORTC QLQ-C30 and STO22) questionnaires which are completed before surgery and 1, 3, 6 months, and 1 year after surgery. χ2 test will be used for the primary endpoint, while analysis of covariance will be used to compare the overall changes of QOL between the two groups.Ethics and disseminationThis trial was approved by the Ethics Committee of the Chinese PLA General Hospital. The trial's results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numberChiCTR2000032670.

Project description:BackgroundBillroth I (B-I) gastroduodenostomy is an anastomotic procedure that is widely performed after gastric resection for distal gastric cancer. A circular stapler often is used for B-I gastroduodenostomy in open and laparoscopic-assisted distal gastrectomy. Recently, totally laparoscopic distal gastrectomy (TLDG) has been considered less invasive than laparoscopic-assisted gastrectomy, and many institutions performing laparoscopic-assisted distal gastrectomy are trying to progress to TLDG without markedly changing the anastomosis method. The purpose of this report is to introduce the technical details of new methods of intracorporeal gastroduodenostomy using either a circular or linear stapler and to evaluate their technical feasibility and safety.MethodsSeventeen patients who underwent TLDG with the intracorporeal double-stapling technique using a circular stapler (n = 7) or the book-binding technique (BBT) using a linear stapler (n = 10) between February 2010 and April 2011 were enrolled in the study. Clinicopathological data, surgical data, and postoperative outcomes were analyzed.ResultsThere were no intraoperative complications or conversions to open surgery in any of the 17 patients. The usual postoperative complications following gastroduodenostomy, such as anastomotic leakage and stenosis, were not observed. Anastomosis took significantly longer to complete with DST (64 ± 24 min) than with BBT (34 ± 7 min), but more stapler cartridges were needed with BBT than with DST.ConclusionsTLDG using a circular or linear stapler is feasible and safe to perform. DST will enable institutions performing laparoscopic-assisted distal gastrectomy with circular staplers to progress to TLDG without problems, and this progression may be more economical because fewer stapler cartridges are used during surgery. However, if an institution has already been performing δ anastomosis in TLDG but has been experiencing certain issues with δ anastomosis, converting from δ anastomosis to BBT should be beneficial.

Dataset Information

A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol).

Publications

A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol).

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