Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes

February 6, 2012 updated by: feng Zheng

A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer Comorbid With Type 2 Diabetes

Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Recruiting
        • Dongfang Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yu Wang, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosed with Type 2 diabetes
  2. Diagnosed with gastric cancer

Exclusion Criteria:

  1. Type 1 diabetes
  2. Unresectable cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Billroth II
After stomach resection, the remnant stomach is connected to the jejunum.
Procedure: Stomach-small intestine reconstruction
Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes
ACTIVE_COMPARATOR: Roux en Y
After stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum.
Procedure: Stomach-small intestine reconstruction
Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 1 year after surgery
  1. Fasting and postprandial glycemic levels, HbA1C
  2. Number of anti-diabetic drugs
  3. Dosage of anti-diabetic drugs
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status assessment
Time Frame: 1 year after surgery
  1. Body mass index
  2. Anthropometric analysis
  3. Plasma concentrations of albumin, pre-albumin, transferrin,and CRP
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

feng Zheng

Investigators

  • Principal Investigator: Yu Wang, M.D, Dongfang Hospital, Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ANTICIPATED)

February 1, 2012

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (ESTIMATE)

February 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DongFang
  • FNSP2009Y0039 (OTHER_GRANT: Fujian Natural Science Project)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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