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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01528059
Enrollment
110
Registered
2012-02-07
Start date
2012-02-29
Completion date
2013-03-31
Last updated
2012-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Type 2 Diabetes

Keywords

Diabetes, Gastric cancer, Gastric bypass

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.

Interventions

PROCEDUREStomach-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

Sponsors

feng Zheng
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Type 1 diabetes 2. Unresectable cancers

Design outcomes

Primary

MeasureTime frameDescription
Glycemic control1 year after surgery1. Fasting and postprandial glycemic levels, HbA1C 2. Number of anti-diabetic drugs 3. Dosage of anti-diabetic drugs

Secondary

MeasureTime frameDescription
Nutritional status assessment1 year after surgery1. Body mass index 2. Anthropometric analysis 3. Plasma concentrations of albumin, pre-albumin, transferrin,and CRP

Countries

China

Contacts

Primary ContactYu Wang, M.D
flyfishwang@hotmail.com13805019453
Backup ContactZhongdong Zhou, M.D
fzptwk@21cn.com13705038043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026