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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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Early gastric cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 27, 2011
Last Updated
September 12, 2012
Sponsor
Yonsei University
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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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