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
2 other identifiers
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Feb 2012
Shorter than P25 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 7, 2012
February 1, 2012
Same day
February 2, 2012
February 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic control
1. Fasting and postprandial glycemic levels, HbA1C 2. Number of anti-diabetic drugs 3. Dosage of anti-diabetic drugs
1 year after surgery
Secondary Outcomes (1)
Nutritional status assessment
1 year after surgery
Study Arms (2)
Billroth II
ACTIVE COMPARATORAfter stomach resection, the remnant stomach is connected to the jejunum.
Roux en Y
ACTIVE COMPARATORAfter stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum.
Interventions
Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes
Eligibility Criteria
You may qualify if:
- Diagnosed with Type 2 diabetes
- Diagnosed with gastric cancer
You may not qualify if:
- Type 1 diabetes
- Unresectable cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- feng Zhenglead
Study Sites (1)
DongFang Hospital
Fuzhou, Fujian, 350025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Wang, M.D
Dongfang Hospital, Xiamen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 2, 2012
First Posted
February 7, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2012
Study Completion
March 1, 2013
Last Updated
February 7, 2012
Record last verified: 2012-02