Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539769
• Other study ID #: KNUCH 2017-07-011
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Kyungpook National University Chilgok Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Stomach Neoplasms

Intervention

Procedure:
• conventional BI
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with conventional Billroth I gastroduodenostomy.
• long-limb BII
After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Billroth II gastrojejunostomy using 100 cm-long biliopancreatic limb.
• long-limb RY group
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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
Kyungpook National University Chilgok Hospital	Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes remission rate	the rate of patients achieving HbA1c < 6.5% without antidiabetic medications	at 6 months after surgery