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

Fujian Medical University

Status: Unknown

Conditions: Stomach Neoplasms

Treatments: Procedure: Totally laparoscopic distal gastrectomy; Procedure: Laparoscopy-assisted distal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02289183

2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Totally laparoscopic distal gastrectomy

Experimental group

Description:

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.

Treatment:

Procedure: Totally laparoscopic distal gastrectomy

Laparoscopy-assisted distal gastrectomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Laparoscopy-assisted distal gastrectomy