Safety and Efficacy of Long Limb Roux-en Y Reconstruction (LoLiRoRe)

August 30, 2012 updated by: Seung Ho Choi, Gangnam Severance Hospital

Long Limb Roux-en Y Reconstruction After Gastrectomy As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Gastric Cancer Patients - a Pilot Project to Validate a Prospective Randomized Control Trial

We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type II diabetes in the world is increasing rapidly, and it is known that patients with type II diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired glucose metabolism.

In Asia, most type II diabetes are not morbidly obese and still, it is controversy whether metabolic surgery is effective or not in non-morbid obese patients. As life expectancy is increased, the number of patients with gastric cancer and T2DM is increased as well.

Recently, we studied the outcome of T2DM after gastrectomy and conventional reconstruction in non-obese gastric cancer patients.(Kim JW et al, World J Gastroenterol 2012;18:49) The study was a large-series retrospective study including about 400 patients and the result regarding DM improvement was not satisfactory. Based on our previous results, it is needed to find more effective way to resolve the type II diabetes in gastrectomized patients with gastric cancer.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed gastric cancer with potentially curable state
  • Non-obese (Body mass index: less than 30 kg/m2)

  • Have a history of Type 2 DM over 6 months (diagnosed by ADA criteria)

    1. HBA1c: more than 6.5 %, or Fasting glucose: more than 126 mg/dl (7.0mmol/L) or 2-h plasma glucose: more than 200mg/dl during an OGTT or classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose: more than 200mg/dl
    2. Anti-GAD antibody (-), Anti-islet antibody (-)
  • C-peptide level: above 1ng/ml

Exclusion Criteria:

  • Patient who receive non-curative operation
  • Patient who have less than one year life expectancy
  • Pregnant patient
  • Acute inflammation status patient
  • Chronic renal disease patient (Serum creatin level: more than 1.5mg/dl)
  • Chronic liver disease patient (Serum AST or ALT level: more than twice of upper limit of normal range)
  • Have a history of receiving medications such as dipeptidyl peptidase IV(DPP- IV) inhibitor or glucagon like peptide-I (GLP-I) analogue

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Long limb Roux-en Y reconstruction
Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
Procedure: Long limb Roux-en Y reconstruction
After radical gastrectomy, the gastrointestinal tract was reconstructed by Roux-en-Y gastrojejunostomy or esophagojejunostomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis
Other Names:
  • modified Roux-en Y

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: Until end of study (on average 14.8 months)

For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected.

*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.

For the evaluation of long-term safety, the patients were evaluated every month after discharge.
Until end of study (on average 14.8 months)
HbA1c
Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).

HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Hemoglobin
Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Albumin
Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of long-term safety, albumin was measured to determine malnutrition.
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Operation Related Mortality
Time Frame: Until end of study (on average 14.8 months)
Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.
Until end of study (on average 14.8 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Matsuda Index
Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Matsuda Index(Insulin Sensitivity Index) was measured.

The Matsuda index was obtained using the following formula:

Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
QUICKI
Time Frame: Before operation , 6 months after operation , Until end of study (on average 14.8 months)

The quantitative insulin sensitivity check index (QUICKI) was measured.

The QUICKI was obtained using the following formula:

1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
Before operation , 6 months after operation , Until end of study (on average 14.8 months)
HOMA-IR
Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.

HOMA-IR was obtained using the following formula:

Glucose(mg/dl) x Insulin/405
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
HOMA-B
Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.

HOMA-B was obtained using the following formula:

225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Body Mass Index
Time Frame: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)

BMI(Body Mass index , kg/㎡) was measured.

BMI was obtained using the following formula:

Weight (kg) / (Height (m) x Height (m))
Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)
Matsuda Index : Good Response Group
Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group.

The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:

Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
QUICKI : Good Response Group
Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.

The QUICKI is obtained using the following formula:

1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HOMA-IR : Good Response Group
Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin resistance after operation in good response group.

HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.

HOMA-IR was obtained using the following formula:

Glucose(mg/dl) x Insulin/405
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HOMA-B : Good Response Group
Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.

HOMA-B was obtained using the following formula:

225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Body Mass Index : Good Response Group
Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of weight change after operation in good response group.

BMI(Body Mass index , kg/㎡) was measured.

BMI was obtained using the following formula:

Weight (kg) / (Height (m) x Height (m))
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HbA1c : Good Response Group
Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of HbA1c after operation in good response group.

HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)

The HbA1c was calculated as a ratio to total hemoglobin.
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Hemoglobin : Good Response Group
Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group.
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Albumin : Good Response Group
Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety.
Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Investigators

  • Principal Investigator: Seung Ho Choi, M.D., Ph.D., Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (ESTIMATE)

June 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • seungho-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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