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Trial Title:
Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes
NCT ID:
NCT01528059
Condition:
Gastric Cancer
Type 2 Diabetes
Conditions: Official terms:
Stomach Neoplasms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Conditions: Keywords:
Diabetes
Gastric cancer
Gastric bypass
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Stomach-small intestine reconstruction
Description:
Billroth II or Roux en Y reconstruction will be performed after gastric resection in
stomach patients co-morbid with type 2 diabetes
Arm group label:
Billroth II
Arm group label:
Roux en Y
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosed with Type 2 diabetes
2. Diagnosed with gastric cancer
Exclusion Criteria:
1. Type 1 diabetes
2. Unresectable cancers
Gender:
All
Minimum age:
30 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
DongFang Hospital
Address:
City:
Fuzhou
Zip:
350025
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Wang, M.D
Phone:
13805019453
Email:
flyfishwang@hotmail.com
Contact backup:
Last name:
ZhongDong Zhou, M.D
Phone:
13705038043
Email:
fzptwk@21cn.com
Investigator:
Last name:
Yu Wang, M.D
Email:
Principal Investigator
Start date:
February 2012
Completion date:
March 2013
Lead sponsor:
Agency:
feng Zheng
Agency class:
Other
Source:
Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01528059
