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

Primary Purpose

Gastric Cancer, Type 2 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Stomach-small intestine reconstruction
Sponsored by
feng Zheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Diabetes, Gastric cancer, Gastric bypass

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Type 1 diabetes
  2. Unresectable cancers

Sites / Locations

  • DongFang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Billroth II

Roux en Y

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nutritional status assessment
Body mass index Anthropometric analysis Plasma concentrations of albumin, pre-albumin, transferrin,and CRP

Full Information

First Posted
February 2, 2012
Last Updated
February 6, 2012
Sponsor
feng Zheng
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1. Study Identification

Unique Protocol Identification Number
NCT01528059
Brief Title
Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
feng Zheng

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Type 2 Diabetes
Keywords
Diabetes, Gastric cancer, Gastric bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Billroth II
Arm Type
Active Comparator
Arm Description
After stomach resection, the remnant stomach is connected to the jejunum.
Arm Title
Roux en Y
Arm Type
Active Comparator
Arm Description
After stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum.
Intervention Type
Procedure
Intervention Name(s)
Stomach-small intestine reconstruction
Intervention Description
Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes
Primary Outcome Measure Information:
Title
Glycemic control
Description
Fasting and postprandial glycemic levels, HbA1C Number of anti-diabetic drugs Dosage of anti-diabetic drugs
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Nutritional status assessment
Description
Body mass index Anthropometric analysis Plasma concentrations of albumin, pre-albumin, transferrin,and CRP
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Type 2 diabetes Diagnosed with gastric cancer Exclusion Criteria: Type 1 diabetes Unresectable cancers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, M.D
Phone
13805019453
Email
flyfishwang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongdong Zhou, M.D
Phone
13705038043
Email
fzptwk@21cn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Wang, M.D
Organizational Affiliation
Dongfang Hospital, Xiamen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DongFang Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Wang, M.D
Phone
13805019453
Email
flyfishwang@hotmail.com
First Name & Middle Initial & Last Name & Degree
ZhongDong Zhou, M.D
Phone
13705038043
Email
fzptwk@21cn.com
First Name & Middle Initial & Last Name & Degree
Yu Wang, M.D

12. IPD Sharing Statement

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

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