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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01528059
• Other study ID #: DongFang
• Secondary ID: FNSP2009Y0039
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 2, 2012
• Last updated: February 6, 2012
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2012
• Source: Xiamen University
• Contact: Yu Wang, M.D
• Phone: 13805019453
• Email: flyfishwang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with Type 2 diabetes

2. Diagnosed with gastric cancer

Exclusion Criteria:

1. Type 1 diabetes

2. Unresectable cancers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Gastric Cancer
• Stomach Neoplasms
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
China	DongFang Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
feng Zheng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Fasting and postprandial glycemic levels, HbA1C; Number of anti-diabetic drugs; Dosage of anti-diabetic drugs	1 year after surgery	No
Secondary	Nutritional status assessment	Body mass index; Anthropometric analysis; Plasma concentrations of albumin, pre-albumin, transferrin,and CRP	1 year after surgery	No