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

Phase 2

• Conditions: Gastric Cancer; Type 2 Diabetes
• Interventions: Procedure: Stomach-small intestine reconstruction

• Registration Number: NCT01528059
• Lead Sponsor: feng Zheng

Brief 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.

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 Timeline

• Status Verified: 2012-02
• Study Start: 2012-02
• Primary Completion: 2012-02
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-06
• Last Update Submitted: 2012-02-06
• Study First Posted: 2012-02-07
• Last Update Posted: 2012-02-07
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

1. Type 1 diabetes
2. Unresectable cancers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Billroth II	Stomach-small intestine reconstruction	After stomach resection, the remnant stomach is connected to the jejunum.
Roux en Y	Stomach-small intestine reconstruction	After stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum.

Primary Outcome Measures

Name	Time	Method
Glycemic control	1 year after surgery	1. Fasting and postprandial glycemic levels, HbA1C; 2. Number of anti-diabetic drugs; 3. Dosage of anti-diabetic drugs

Secondary Outcome Measures

Name	Time	Method
Nutritional status assessment	1 year after surgery	1. Body mass index; 2. Anthropometric analysis; 3. Plasma concentrations of albumin, pre-albumin, transferrin,and CRP

Trial Locations

Locations (1)

DongFang Hospital; 🇨🇳 Fuzhou, Fujian, China