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

This study is currently recruiting participants.
Verified February 2012 by Xiamen University
Sponsor:
Information provided by (Responsible Party):
feng Zheng, Xiamen University
ClinicalTrials.gov Identifier:
NCT01528059
First received: February 2, 2012
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Type 2 Diabetes
 Procedure: Stomach-small intestine reconstruction
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xiamen University:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    1. Fasting and postprandial glycemic levels, HbA1C
    2. Number of anti-diabetic drugs
    3. Dosage of anti-diabetic drugs


Secondary Outcome Measures:
  • Nutritional status assessment [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
    1. Body mass index
    2. Anthropometric analysis
    3. Plasma concentrations of albumin, pre‐albumin, transferrin,and CRP


Estimated Enrollment: 110
Study Start Date: February 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Type 1 diabetes
  2. Unresectable cancers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528059

Contacts
Contact: Yu Wang, M.D 13805019453 flyfishwang@hotmail.com
Contact: Zhongdong Zhou, M.D 13705038043 fzptwk@21cn.com

Locations
China, Fujian
DongFang Hospital Recruiting
Fuzhou, Fujian, China, 350025
Contact: Yu Wang, M.D     13805019453     flyfishwang@hotmail.com    
Contact: ZhongDong Zhou, M.D     13705038043     fzptwk@21cn.com    
Principal Investigator: Yu Wang, M.D            
Sponsors and Collaborators
feng Zheng
Investigators
Principal Investigator: Yu Wang, M.D Dongfang Hospital, Xiamen University
  More Information

No publications provided

Responsible Party: feng Zheng, MD, Xiamen University
ClinicalTrials.gov Identifier: NCT01528059     History of Changes
Other Study ID Numbers: DongFang, FNSP2009Y0039
Study First Received: February 2, 2012
Last Updated: February 6, 2012
Health Authority: China: Ministry of Health

Keywords provided by Xiamen University:
Diabetes
Gastric cancer
Gastric bypass

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Stomach Neoplasms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 16, 2013