Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
NCT ID: NCT04889859
Last Updated: 2023-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-05-01
2023-02-28
Brief Summary
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Detailed Description
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The reconstruction method will be randomly assigned among long-Roux limb Roux-en-Y (with 100 cm-long Roux limb \& 50cm-long biliopancreatic limb) or long-biliopancreatic limb Roux-en-Y (with 50 cm-long Roux limb \& 100cm-long biliopancreatic limb) reconstruction methods.
All the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 3 months, 6 months postoperatively, and serum glucose, as well as incretin hormones, will be serially measured. Fecal samples will be obtained preoperatively and at 3 months after surgery for gut microbiota analyses.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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long RL group
long Roux limb Roux-en-Y reconstruction
long Roux limb Roux-en-Y reconstruction
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.
long BPL group
long biliopancreatic limb Roux-en-Y reconstruction
long biliopancreatic limb Roux-en-Y reconstruction
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.
Interventions
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long Roux limb Roux-en-Y reconstruction
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.
long biliopancreatic limb Roux-en-Y reconstruction
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
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Inclusion Criteria
* Those who are expected to undergo laparoscopic distal gastrectomy
Exclusion Criteria
2. previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
3. other malignancies in recent 5 years
4. vulnerable patients (pregnant women, those with cognitive impairment, etc)
5. ECOG-PS ≥ 2
6. participating in other clinical trials within 6 months
ALL
No
Sponsors
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Kyungpook National University Chilgok Hospital
OTHER
Responsible Party
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Ji Yeon Park
Ji Yeon Park
Principal Investigators
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Ji Yeon Park, MD
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Chilgok Hospital
Locations
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Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Countries
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Other Identifiers
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KNUCH 2019-04-004
Identifier Type: -
Identifier Source: org_study_id
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