Overview

This trial is active, not recruiting.

Condition stomach neoplasms
Treatments totally laparoscopic distal gastrectomy, laparoscopy-assisted distal gastrectomy
Phase phase 3
Sponsor Fujian Medical University
Start date January 2015
End date December 2017
Trial size 240 participants
Trial identifier NCT02289183, 2015-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
totally laparoscopic distal gastrectomy
Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy
(Active Comparator)
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.
laparoscopy-assisted distal gastrectomy
Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis

Primary Outcomes

Measure
3-year disease free survival rate
time frame: 36 months

Secondary Outcomes

Measure
Morbidity and mortality
time frame: 30 days;36 months
Intraoperative situation
time frame: 1 day
Postoperative recovery course
time frame: 10 days
Postoperative nutritional status and quality of life
time frame: 12 months
Inflammatory and immune response
time frame: 7 days
3-year overall survival rate
time frame: 36 months
3-year recurrence pattern
time frame: 36 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Age from 18 to 75 years (including 18 and 75 years old) - Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy - cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition - Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy - Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) - American Society of Anesthesiology score (ASA) class I, II, or III - Written informed consent Exclusion Criteria: - Women during pregnancy or breast-feeding - Severe mental disorder - History of previous upper abdominal surgery (except laparoscopic cholecystectomy) - History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection - Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging - History of other malignant disease within past five years - History of previous neoadjuvant chemotherapy or radiotherapy - History of unstable angina or myocardial infarction within past six months - History of cerebrovascular accident within past six months - History of continuous systematic administration of corticosteroids within one month - Requirement of simultaneous surgery for other disease - Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer - FEV1<50% of predicted values

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Fujian Medical University.