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

• ClinicalTrials.gov Identifier: NCT04539769
• Recruitment Status: Completed
• First Posted: September 7, 2020
• Last Update Posted: September 7, 2020
• Sponsor: Kyungpook National University Chilgok Hospital
• Collaborator: Kyungpook National University Hospital
• Information provided by (Responsible Party): Ji Yeon Park, Kyungpook National University Chilgok Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Stomach Neoplasms; Diabetes Mellitus, Type 2	Procedure: conventional BI; Procedure: long-limb BII; Procedure: long-limb RY group	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
• Actual Study Start Date: September 1, 2017
• Actual Primary Completion Date: April 30, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: BI group; Conventional Billroth I reconstruction	Procedure: conventional BI; After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with conventional Billroth I gastroduodenostomy.
Experimental: BII group; Billroth II reconstruction with 100-cm long biliopancreatic limb	Procedure: 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.
Experimental: RY group; Roux-en-Y reconstruction with 100-cm long Roux limb	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Diabetes remission rate [ Time Frame: at 6 months after surgery ]
   the rate of patients achieving HbA1c < 6.5% without antidiabetic medications

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Kyungpook National University Chilgok Hospital

Daegu, Korea, Republic of, 41404

Sponsors and Collaborators

Kyungpook National University Chilgok Hospital

Kyungpook National University Hospital

More Information

• Responsible Party: Ji Yeon Park, Dr., Kyungpook National University Chilgok Hospital
• ClinicalTrials.gov Identifier: NCT04539769
• Other Study ID Numbers: KNUCH 2017-07-011
• First Posted: September 7, 2020
• Last Update Posted: September 7, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stomach Neoplasms; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases