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

feng Zheng

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gastric Cancer; Type 2 Diabetes

Treatments: Procedure: Stomach-small intestine reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01528059

DongFang

FNSP2009Y0039 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Type 1 diabetes
2. Unresectable cancers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Billroth II

Active Comparator group

Description:

After stomach resection, the remnant stomach is connected to the jejunum.

Treatment:

Procedure: Stomach-small intestine reconstruction

Roux en Y

Active Comparator group

Description:

After stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum.

Treatment:

Procedure: Stomach-small intestine reconstruction