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

NCT ID: NCT02289183

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Totally laparoscopic distal gastrectomy

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.

Group Type EXPERIMENTAL

Totally laparoscopic distal gastrectomy

Intervention Type PROCEDURE

Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy

Laparoscopy-assisted distal gastrectomy

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.

Group Type ACTIVE_COMPARATOR

Laparoscopy-assisted distal gastrectomy

Intervention Type PROCEDURE

Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis

Interventions

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Totally laparoscopic distal gastrectomy

Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy

Intervention Type PROCEDURE

Laparoscopy-assisted distal gastrectomy

Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chang-Ming Huang, Prof.

Fujian Medical University Union Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Chaohui Zheng, M.D.

Role: STUDY_DIRECTOR

Fujian Medical University Union Hospital

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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2015-01

Identifier Type: -

Identifier Source: org_study_id

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