Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

Kyungpook National University Chilgok Hospital

Status: Completed

Conditions: Stomach Neoplasm; Diabetes Mellitus, Type 2

Treatments: Procedure: long biliopancreatic limb Roux-en-Y reconstruction; Procedure: long Roux limb Roux-en-Y reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04889859

KNUCH 2019-04-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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

1. baseline fasting C-peptide level < 1.0 ng/dL (who had the possibility of type 1 diabetes)
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

long RL group

Active Comparator group

Description:

long Roux limb Roux-en-Y reconstruction

Treatment:

Procedure: long Roux limb Roux-en-Y reconstruction

long BPL group

Experimental group

Description:

long biliopancreatic limb Roux-en-Y reconstruction

Treatment:

Procedure: long biliopancreatic limb Roux-en-Y reconstruction