Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus
Primary Purpose
Gastric Cancer, Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Roux-en Y gastrojejunostomy
Gastroduodenostomy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Early gastric cancer
Eligibility Criteria
Inclusion Criteria:
- Patient who are older than 20 years and younger than 80 years
- Histologically confirmed gastric adenocarcinoma located lower one third of stomach
- Postoperative confirmed pT1N0, pT2N0, pT1N1
- Informed consent
Exclusion Criteria:
- Previous history of treatment for other malignancy or inflammatory disease
- Preoperative uncontrolled serious comorbidity
- Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.)
- Patient who experience any complications requiring reoperation following gastrectomy
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Gastroduodenostomy
Roux-en Y gastrojejunostomy
Arm Description
Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer
Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer
Outcomes
Primary Outcome Measures
Blood sugar stabilization after gastrectomy
By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01375738
Brief Title
Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus
Official Title
The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes.
Detailed Description
Purpose:
To investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes
To investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods
To evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes
Contents:
Evaluation of the status of diabetes in gastric cancer patients with DM after gastrectomy
Comparison of two reconstruction types after gastrectomy Bypass duodenum and upper jejunum: Roux-en-Y gastrojejunostomy Preservation of duodenal passage: Gastroduodenostomy
Analysis for biochemical markers reflecting diabetic status: fasting glucose, postprandial 2h glucose, HbA1c, C-peptide, lipid profile
Correlation of parameters associated with diabetes and GI hormones
Measurement of GI hormones which have an effect on glucose tolerance
Insulin, glucagon, IGF-1, GLP-1, Neuropeptide Y, Ghrelin, Leptin
Correlation of reconstruction methods, parameters of diabetes and GI hormone levels
Evaluation of mechanism of Roux-en-Y gastrojejunostomy on controlling diabetes
Evaluation of Feasibility of Roux-en-Y gastrojejunostomy in gastric cancer surgery in patients with DM
Degree of high blood glucose control, the amount of antidiabetic medication, costs for DM treatment, quality of life assessment
Analysis for the mechanism of gastrointestinal physiology to diabetes control
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Diabetes
Keywords
Early gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastroduodenostomy
Arm Type
Active Comparator
Arm Description
Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer
Arm Title
Roux-en Y gastrojejunostomy
Arm Type
Experimental
Arm Description
Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer
Intervention Type
Procedure
Intervention Name(s)
Roux-en Y gastrojejunostomy
Intervention Description
After subtotal gastrectomy with lymph node dissection, the jejunum is transected 25~30cm distal to the ligament of Treitz. Distal jejunum is drawn up and sutured to the gastric remnant and the proximal jejunum is anastomosed to the distal jejunum at 30~40cm from the new gastric-jejunal junction.
Intervention Type
Procedure
Intervention Name(s)
Gastroduodenostomy
Intervention Description
After subtotal gastrectomy with lymph node dissection, the gastric remnant is anastomosed to duodenum 1st portion with circular or linear staplers and the artificial lesser curvature is repaired with linear stapler.
Primary Outcome Measure Information:
Title
Blood sugar stabilization after gastrectomy
Description
By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.
Time Frame
three months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who are older than 20 years and younger than 80 years
Histologically confirmed gastric adenocarcinoma located lower one third of stomach
Postoperative confirmed pT1N0, pT2N0, pT1N1
Informed consent
Exclusion Criteria:
Previous history of treatment for other malignancy or inflammatory disease
Preoperative uncontrolled serious comorbidity
Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.)
Patient who experience any complications requiring reoperation following gastrectomy
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Yeong An, MD
Phone
82-2-2228-2100
Email
jar319@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Yoo-Min Kim, MD
Email
AUG79@yuhs.ac
12. IPD Sharing Statement
Citations:
PubMed Identifier
20863527
Citation
Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30.
Results Reference
background
PubMed Identifier
34523717
Citation
Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
Results Reference
derived
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Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus
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