Impact of Biliopancreatic Limb Length on Diabetes Followi... | NCT04889859

Studies
Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

NCT04889859

Sponsor

Kyungpook National University Chilgok Hospital

Status

Completed

Last Update Posted

Mar 14, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Stomach Neoplasm
Diabetes Mellitus, Type 2

Interventions

long Roux limb Roux-en-Y reconstruction
long biliopancreatic limb Roux-en-Y reconstruction

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Feb 28, 2023Actual

First Submitted Date

May 9, 2021

First Submission Date that Met QC Criteria

May 12, 2021

First Posted Date

May 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2023

Last Update Posted Date

Mar 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Yeon Park, Ji Yeon Park, Kyungpook National University Chilgok HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University Chilgok HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
long RL group	Active Comparator	long Roux limb Roux-en-Y reconstruction	Procedure: long Roux limb Roux-en-Y reconstruction
long BPL group	Experimental	long biliopancreatic limb Roux-en-Y reconstruction	Procedure: long biliopancreatic limb Roux-en-Y reconstruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
long Roux limb Roux-en-Y reconstruction	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diabetes remission rate (%)	rate of the patients with HbA1c < 6.5% without medication	6 months

Secondary Outcomes

Measure	Description	Time Frame
delta HbA1c (%)	difference of preoperative HbA1c and postoperative HbA1c	6 months
changes in body mass index (BMI, kg/m2)	difference of preoperative BMI and postoperative BMI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ji Yeon Park, MD	Kyungpook National University Chilgok Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Chilgok Hospital		Daegu		41404	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided