Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

  • STATUS
    Recruiting
  • days left to enroll
    33
  • participants needed
    30
  • sponsor
    Kyungpook National University Chilgok Hospital
Updated on 12 March 2022
diabetes
gastrectomy
lymphadenectomy

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

Description

The present study aimed to compare the changes in glucose metabolism and incretin hormone responses following long-limb bypass Roux-en-Y reconstruction with different biliopancreatic limb lengths after distal gastrectomy in gastric cancer patients with type 2 diabetes. This is a prospective, single-center, randomized controlled trial. 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 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.

Details
Condition Stomach Neoplasm, Diabetes Mellitus, Type 2
Treatment long Roux limb Roux-en-Y reconstruction, long biliopancreatic limb Roux-en-Y reconstruction
Clinical Study IdentifierNCT04889859
SponsorKyungpook National University Chilgok Hospital
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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