Laparoscopic distal gastrectomy for clinical stage I gastric adenocarcinoma: Techniques evolution and oncological outcomes of the first 100 cases

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.

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Prospective randomized controlled study for comparison of 2-dimensional versus 3-dimensional laparoscopic distal gastrectomy for gastric adenocarcinoma

Surgical Endoscopy ◽

10.1007/s00464-020-07587-4 ◽

2020 ◽

Author(s):

Kanghaeng Lee ◽

Sang Il Youn ◽

Yongjoon Won ◽

Sa-Hong Min ◽

Young Suk Park ◽

...

Keyword(s):

Gastric Adenocarcinoma ◽

Distal Gastrectomy ◽

Laparoscopic Distal Gastrectomy ◽

Randomized Controlled Study ◽

Controlled Study ◽

3 Dimensional ◽

Randomized Controlled

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Safety and feasibility of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG 0703)

Gastric Cancer ◽

10.1007/s10120-010-0565-0 ◽

2010 ◽

Vol 13 (4) ◽

pp. 238-244 ◽

Cited By ~ 203

Author(s):

Hitoshi Katai ◽

◽

Mitsuru Sasako ◽

Haruhiko Fukuda ◽

Kenichi Nakamura ◽

...

Keyword(s):

Gastric Cancer ◽

Phase Ii ◽

Phase Ii Trial ◽

Distal Gastrectomy ◽

Clinical Stage ◽

Stage I ◽

Multicenter Phase ◽

Nodal Dissection

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Morbidity and mortality after laparoscopy-assisted and open distal gastrectomy for stage I gastric cancer: Results from a multicenter randomized controlled trial (KLASS-01).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.4 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 4-4 ◽

Cited By ~ 4

Author(s):

Hyuk-Joon Lee ◽

Hyung-Ho Kim ◽

Sang Uk Han ◽

Min-Chan Kim ◽

Woo Jin Hyung ◽

...

Keyword(s):

Gastric Cancer ◽

Randomized Controlled Trial ◽

Distal Gastrectomy ◽

Controlled Trial ◽

Clinical Stage ◽

Wound Complication ◽

Stage I ◽

Open Distal Gastrectomy ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

4 Background: Laparoscopy assisted distal gastrectomy (LADG) is widely performed for gastric cancer in Eastern countries, although large scale prospective data are still lacking. We conducted a phase III, multicenter randomized controlled trial (KLASS-01) to compare the short and long term outcomes of LADG versus open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. Methods: The primary end point was 5-year overall survival. The morbidity within 30 postoperative days and the surgical mortality were compared to evaluate the safety of LADG as a secondary end point. A total of 1,416 patients were randomly assigned to the LADG group (n = 705) or the ODG group (n = 711) between Feb 1, 2006 and Aug 31, 2010. Results: 1,256 were eligible for per protocol (PP) analysis (644 and 612, respectively). The overall complication rate was significantly lower in the LADG group (LADG vs. ODG; 13.0% vs. 19.9%, P =.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs. 7.7%, P <.001). The major intra-abdominal complication (7.6% vs. 10.3%, P =.095) and mortality rates (0.6% vs. 0.3%, P =.450) were similar between groups. Modified intention-to-treat analysis showed similar results with PP analysis. Conclusions: LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG. Clinical trial information: NCT00452751.

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