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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


Phase 2/Phase 3
30 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer, Type 2 Diabetes

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Trial Information

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


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.


Inclusion Criteria:



1. Diagnosed with Type 2 diabetes

2. Diagnosed with gastric cancer

Exclusion Criteria:

1. Type 1 diabetes

2. Unresectable cancers

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Glycemic control

Outcome Description:

Fasting and postprandial glycemic levels, HbA1C Number of anti-diabetic drugs Dosage of anti-diabetic drugs

Outcome Time Frame:

1 year after surgery

Safety Issue:

No

Principal Investigator

Yu Wang, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dongfang Hospital, Xiamen University

Authority:

China: Ministry of Health

Study ID:

DongFang

NCT ID:

NCT01528059

Start Date:

February 2012

Completion Date:

March 2013

Related Keywords:

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

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