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).

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.).

Comparison between the mesenteric fixation method (MEFIX) and conventional methods at preventing the occurrence of Petersen's hernia: a study protocol for a multicenter randomized controlled trial.

BACKGROUND: Petersen's hernia, which occurs after Billroth-II (B-II) or Roux-en-Y (REY) anastomosis, can be reduced by defect closure. This study aims to compare the incidence of bowel obstruction above Clavien-Dindo classification grade III due to Petersen's hernia between the mesenteric fixation method and the conventional methods after laparoscopic or robotic gastrectomy. METHODS: This study was designed as prospective, single-blind, non-inferiority randomized controlled multicenter trial in Korea. Patients with histologically diagnosed gastric cancer of clinical stages I, II, or III who underwent B-II or REY anastomosis after laparoscopic or robotic gastrectomy are enrolled in this study. Participants who meet the inclusion criteria are randomly assigned to two groups: a CLOSURE group that underwent conventional Petersen's defect closure method and a MEFIX group that underwent the mesenteric fixation method. The primary endpoint is the number of patients who underwent surgery for bowel obstruction caused by Petersen's hernia within 3 years after laparoscopic or robotic gastrectomy. DISCUSSION: This trial is expected to provide high-level evidence showing that the MEFIX method can quickly and easily close Petersen's defect without increased postoperative complications compared to the conventional method. TRIAL REGISTRATION: ClinicalTrials.gov NCT05105360. Registered on November 3, 2021.

Actual 3-Year Survival After Reduced-Port Laparoscopic Distal Gastrectomy for Gastric Cancer (RpLDG): a Propensity Score Matching Analysis.

BACKGROUND: Total laparoscopic distal gastrectomy for early gastric cancer has been widely accepted; however, reduced-port laparoscopic distal gastrectomy has not gained the same popularity because of technical difficulties and oncologic safety issues. This study aimed to analyze the oncologic safety and short-term surgical outcomes of patients who underwent reduced-port laparoscopic distal gastrectomy (RpLDG) for gastric cancer. METHODS: Consecutive patients who underwent surgical treatment between January 2016 and May 2018 were included in this study. Of the 833 patients enrolled, 158 underwent RpLDG and were propensity-matched with 158 patients who underwent conventional port laparoscopic distal gastrectomy (CpLDG). The groups were compared in terms of short-term outcomes and disease-free and overall survival rates. RESULTS: The RpLDG group had shorter operation times (161.8 min vs. 189.0 min, p < 0.00) and shorter postoperative hospital stays (7.6 days vs. 9.1 days, p = 0.04) compared to the CpLDG group. Estimated blood loss was lower in the RpLDG group than in the CpLDG group (52.6 mL vs. 73.7 mL, p < 0.00), while hospital costs incurred by the RpLDG group were lower than those of the CpLDG group (10,033.7 vs. 11,016.8 USD, p < 0.00). No statistical differences were found regarding overall morbidity and occurrence of surgical complications of grade III or higher, as defined by the Clavien-Dindo classification. Furthermore, no significant differences between RpLDG and CpLDG were found in 3-year disease-free (99.4% vs. 98.1%; p = 0.42) and 3-year overall survival rates (98.7% vs. 96.8%; p = 0.25). CONCLUSION: Patients who underwent RpLDG had better short-term surgical outcomes than those who underwent CpLDG in terms of operation time, estimated blood loss, duration of hospital stay, and hospital costs. The oncologic safety of RpLDG was satisfactory.

Can Proximal Gastrectomy with Double-Tract Reconstruction Replace Total Gastrectomy? A Propensity Score Matching Analysis.

BACKGROUND: This retrospective cohort study compared proximal gastrectomy (PG) with double-tract reconstruction (DTR) versus total gastrectomy (TG) with Roux-en-Y reconstruction in terms of clinical outcomes. METHODS: All consecutive patients with upper early gastric cancer (EGC) who underwent PG-DTR or TG in 2008-2016 were selected. TG patients who matched PG-DTR patients in age, sex, body mass index, clinical stage, and ASA score were selected by propensity score matching. Groups were compared in terms of clinicopathological characteristics, clinical outcomes, early (≤ 30 days), late (> 30 days), and severe (Clavien-Dindo grade ≥ III) postoperative complications, 1-year reflux morbidity, recurrence, and mortality. RESULTS: Of 322 patients, 52 underwent PG-DTR. A matching TG group of 52 patients was selected. The PG-DTR group had smaller tumors (p = 0.02), smaller proximal and distal resection margins (p = 0.01, p < 0.01), and fewer retrieved lymph nodes (p < 0.01). PG-DTR associated with shorter times to diet and hospital stay (both p = 0.02). Groups did not differ in early (11.3 vs. 19.2%, p = 0.19), late (1.9 vs. 5.7%, p = 0.31), or severe complication rates (7.7 vs. 13.5%, p = 0.34). At 1 year, the groups did not differ in reflux symptoms (Visick score) or endoscopic esophagitis (Los Angeles Classification). There were no recurrences. Five-year overall survival rates were 100 and 81.6% (p = 0.02), respectively. CONCLUSION: PG-DTR associated with better clinical outcomes and survival. Complication and reflux rates were similar. PG-DTR may be suitable for upper EGC.

Comparison Between Billroth-II with Braun and Roux-en-Y Reconstruction After Laparoscopic Distal Gastrectomy.

PURPOSE: This study aims to compare the effectiveness of Billroth-II with Braun and Roux-en-Y reconstruction after laparoscopic distal gastrectomy. METHODS: From April 2010 to August 2012, 66 patients underwent laparoscopic distal gastrectomy (Billroth-II with Braun reconstruction, 26; Roux-en-Y, 40). The patients' data were collected prospectively and reviewed retrospectively. RESULTS: The mean operation and reconstruction times were statistically shorter for Billroth-II with Braun reconstruction than Roux-en-Y (198.1 ± 33.0 vs. 242.3 ± 58.1 min, p = 0.001). One case of postoperative stricture was observed in each group. One case each of intra-abdominal abscess and delayed gastric emptying occurred in the Billroth-II with Braun group. At 1 year postoperatively, gastric residue and reflux esophagitis were not significantly different between the groups. Gastritis and bile reflux were more frequently observed in the Billroth-II with Braun group (p = 0.004 and p < 0.001, respectively). At 2 years postoperatively, gastric residue was not significantly different, but gastritis, bile reflux, and esophagitis were more frequent in the Billroth-II with Braun group (p = 0.029, p < 0.001, and p = 0.036, respectively). CONCLUSION: The postoperative effectiveness of Roux-en-Y reconstruction may be superior to Billroth-II with Braun reconstruction after laparoscopic distal gastrectomy.