Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

The totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy will be performed for the treatment of patients with distal gastric cancer assigned to this group.

The laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis will be performed for the treatment of patients with distal gastric cancer assigned to this group.

Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy

Totally laparoscopic distal gastrectomy

Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis

Laparoscopy-assisted distal gastrectomy

Changming Huang, M.D.,Ph.D.

Chaohui Zheng, M.D.

The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.

A prospective randomized comparison of the modified delta-shaped gastroduodenostomy in totally laparoscopic surgery and Billroth-I anastomosis in laparoscopy-assisted surgery for distal gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the modified technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer

Prospective Randomized Controlled Trial on Clinical Application Value of Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery and Billroth-I Anastomosis in Laparoscopy-assisted Surgery for Distal Gastric Cancer

The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.

Operation time, intraoperative blood loss and transfusion volume, conversive rate, intraoperative bleeding and viscera damage, and incision length are used to access the intraoperative situation

Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.

The variation of weight, cholesterol and albumin on postoperative 3, 6, 9 and 12 months, and the results of endoscopy on postoperative 3 and 12 months are used to access the postoperative nutritional status and quality of life.

The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

Fujian Medical University

Fujian Medical University Union Hospital

Behaviors and Mental Disorders

Quality of Life

The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.

The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.

laparoscopy-assisted distal gastrectomy Group

Dazhi Xu, PHD, MD

Dazhi Xu, PHD，MD

The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.

Although totally laparoscopic distal gastrectomy (TLDG) and laparoscopic-assisted distal gastrectomy (LADG) are both minimally invasive surgeries for gastric cancer with the same surgical treatment principles, in the former, all surgical processes are performed intracorporeally, while, in the latter, extracorporeal gastro-enteric anastomosis is achieved. Whether the procedural differences between TLDG and LADG affect quality of life （QOL）is still under debate.To evaluate how each laparoscopic surgery affect QOL of patients with gastric cancer, it is necessary to compare the postoperative QOL (scoring by questionnaire) between the patients undergoing TLDG and LADG through a multi-center randomized controlled trial.

Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer

Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 1 months postoperative

Scores on the other scales of EORTC QLQ-C30 questionnaire at 1 months postoperative

Scores on EORTC QLQ-C30 questionnaire at 7 day and 1 months postoperative

Scores on the other scales of ST22 questionnaire at 1 months postoperative

Scores on ST22 questionnaire at 7 day and 1 months postoperative

Fudan University

PHD,MD

Symptoms and General Pathology

Postoperative Complications

patients in this arm will receive totally laparoscopic distal gastrectomy

patients in this group will receive laparoscopy-assisted distal gastrectomy

all the surgical procedure would be finished under laparoscopy

totally laparoscopic distal gastrectomy

Xubing Zhang

This study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.

When one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). When he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.

the Outcomes Assessor would not know which approach the patient received.

Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer

there is a plan to make individual participant data (IPD) available to other researchers.

the time from the finish of surgery to discharge

the survival rate at the third year from the finish of surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer	NCT02289183	Stomach Neoplas...	Totally laparos... Laparoscopy-ass...	18 Years - 75 Years	Fujian Medical University
Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer	NCT05541783	Gastric Cancer	laparoscopy-ass... Totally laparos...	20 Years - 80 Years	Fudan University
Totally Laparoscopic Distal Gastrectomy for Gastric Cancer	NCT05556980	Postoperative C...	totally laparos...	18 Years - 80 Years	The First Affiliated Hospital of University of Science and Technology of China
Totally Laparoscopic Distal Gastrectomy for Gastric Cancer	NCT05556980	Postoperative C...	totally laparos...	18 Years - 80 Years	The First Affiliated Hospital of University of Science and Technology of China
Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer	NCT02289183	Stomach Neoplas...	Totally laparos... Laparoscopy-ass...	18 Years - 75 Years	Fujian Medical University
Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer	NCT05541783	Gastric Cancer	laparoscopy-ass... Totally laparos...	20 Years - 80 Years	Fudan University

Spots Global Cancer Trial Database for totally laparoscopic distal gastrectomy