Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
Primary Purpose
Stomach Neoplasms, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
conventional BI
long-limb BII
long-limb RY group
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 7th edition
- Those who are expected to undergo laparoscopic distal gastrectomy
- Body mass index < 30 kg/m2
Exclusion Criteria:
- baseline fasting C-peptide level < 1.0 ng/dL (who had the possibility of type 1 diabetes)
- previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
- other malignancies in recent 5 years
- vulnerable patients (pregnant women, those with cognitive impairment, etc)
- ECOG-PS ≥ 2
- participating in other clinical trials within 6 months
Sites / Locations
- Kyungpook National University Chilgok Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
BI group
BII group
RY group
Arm Description
Conventional Billroth I reconstruction
Billroth II reconstruction with 100-cm long biliopancreatic limb
Roux-en-Y reconstruction with 100-cm long Roux limb
Outcomes
Primary Outcome Measures
Diabetes remission rate
the rate of patients achieving HbA1c < 6.5% without antidiabetic medications
Secondary Outcome Measures
Full Information
NCT ID
NCT04539769
First Posted
August 31, 2020
Last Updated
August 31, 2020
Sponsor
Kyungpook National University Chilgok Hospital
Collaborators
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04539769
Brief Title
Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
Official Title
Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Chilgok Hospital
Collaborators
Kyungpook National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There is a rapidly growing interest in metabolic surgery for the treatment of type 2 diabetes. However, its efficacy in the non-morbidly population is not clear yet and the underlying mechanism remains elusive.
Meanwhile, the incidence of early gastric cancer (EGC) in Korea has gradually increased, the long-term quality of life of the patients with EGC has become an important issue. Since the reconstruction methods after gastric cancer surgery are similar to that of metabolic surgery, some surgeons have attempted to modify the reconstruction methods after standard radical gastrectomy to achieve better glycemic control in gastric cancer patients with type 2 diabetes.
The present study aimed to investigate the changes in glucose metabolism and incretin hormone responses following different types of reconstruction after distal gastrectomy in non-morbidly obese gastric cancer patients with type 2 diabetes. This is a non-randomized, prospective, single-center, phase II pilot study.
Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located at the lower two-thirds of the stomach will only be included. The reconstruction method will be selected among conventional Billroth I, long-limb Billroth II (with 100 cm-long biliopancreatic limb), or long-limb Roux-en-Y (with 100 cm-long Roux limb) reconstruction methods according to the surgeon's preference as well as the size of the remnant stomach. All the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 5 days, 3 months, 6 months postoperatively and serum glucose, as well as incretin hormones, will be serially measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BI group
Arm Type
Active Comparator
Arm Description
Conventional Billroth I reconstruction
Arm Title
BII group
Arm Type
Experimental
Arm Description
Billroth II reconstruction with 100-cm long biliopancreatic limb
Arm Title
RY group
Arm Type
Experimental
Arm Description
Roux-en-Y reconstruction with 100-cm long Roux limb
Intervention Type
Procedure
Intervention Name(s)
conventional BI
Intervention Description
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with conventional Billroth I gastroduodenostomy.
Intervention Type
Procedure
Intervention Name(s)
long-limb BII
Intervention Description
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Billroth II gastrojejunostomy using 100 cm-long biliopancreatic limb.
Intervention Type
Procedure
Intervention Name(s)
long-limb RY group
Intervention Description
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 100 cm-long Roux limb and standard biliopancreatic limb.
Primary Outcome Measure Information:
Title
Diabetes remission rate
Description
the rate of patients achieving HbA1c < 6.5% without antidiabetic medications
Time Frame
at 6 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 7th edition
Those who are expected to undergo laparoscopic distal gastrectomy
Body mass index < 30 kg/m2
Exclusion Criteria:
baseline fasting C-peptide level < 1.0 ng/dL (who had the possibility of type 1 diabetes)
previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
other malignancies in recent 5 years
vulnerable patients (pregnant women, those with cognitive impairment, etc)
ECOG-PS ≥ 2
participating in other clinical trials within 6 months
Facility Information:
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
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