Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
Impact of the Length of Biliopancreatic Limb on Diabetes Associated With the Changes in Incretin Hormone and Gut Microbiota Following Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
1 other identifier
interventional
30
1 country
1
Brief Summary
This is a prospective, randomized controlled trial to investigate the impact of a long biliopancreatic limb of Roux-en-Y reconstruction on diabetes control in patients with concurrent type 2 diabetes and gastric cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Longer than P75 for not_applicable
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
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 9, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedMarch 14, 2023
March 1, 2023
3.8 years
May 9, 2021
March 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
diabetes remission rate (%)
rate of the patients with HbA1c \< 6.5% without medication
6 months
Secondary Outcomes (7)
delta HbA1c (%)
6 months
changes in body mass index (BMI, kg/m2)
up to 6 months
changes in body fat mass (kg)
up to 6 months
changes in lean body mass (kg)
up to 6 months
changes in blood glucose and insulin concentration
up to 6 months
- +2 more secondary outcomes
Study Arms (2)
long RL group
ACTIVE COMPARATORlong Roux limb Roux-en-Y reconstruction
long BPL group
EXPERIMENTALlong biliopancreatic limb Roux-en-Y reconstruction
Interventions
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 50 cm-long biliopancreatic limb.
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 50 cm-long Roux limb and 100 cm-long biliopancreatic limb.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition
- Those who are expected to undergo laparoscopic distal gastrectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Yeon Park, MD
Kyungpook National University Chilgok Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ji Yeon Park
Study Record Dates
First Submitted
May 9, 2021
First Posted
May 17, 2021
Study Start
May 1, 2019
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
March 14, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share