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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seung Ho Choi, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01373346
First received: June 13, 2011
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 2 in Nonobese
Gastric Cancer
Procedure: Long limb Roux-en Y reconstruction

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gangnam Severance Hospital:

Primary Outcome Measures:
  • Morbidity [ Time Frame: Until end of study (on average 14.8 months) ] [ Designated as safety issue: Yes ]

    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.


  • HbA1c [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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.


  • Hemoglobin [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]
    For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.

  • Albumin [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]
    For the evaluation of long-term safety, albumin was measured to determine malnutrition.

  • Operation Related Mortality [ Time Frame: Until end of study (on average 14.8 months) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Matsuda Index [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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)]


  • QUICKI [ Time Frame: Before operation , 6 months after operation , Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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))


  • HOMA-IR [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

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

    HOMA-IR was obtained using the following formula:

    Glucose(mg/dl) x Insulin/405


  • HOMA-B [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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)


  • Body Mass Index [ Time Frame: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months) ] [ Designated as safety issue: No ]

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

    BMI was obtained using the following formula:

    Weight (kg) / (Height (m) x Height (m))


  • Matsuda Index : Good Response Group [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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)]


  • QUICKI : Good Response Group [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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))


  • HOMA-IR : Good Response Group [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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


  • HOMA-B : Good Response Group [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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)


  • Body Mass Index : Good Response Group [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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))


  • HbA1c : Good Response Group [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]

    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.


  • Hemoglobin : Good Response Group [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]
    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.

  • Albumin : Good Response Group [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: modified Roux-en Y

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373346

Locations
Korea, Republic of
GangNam Severance Hospital
Seoul, Korea, Republic of, 146-92
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Seung Ho Choi, Chief of surgery, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT01373346     History of Changes
Other Study ID Numbers: seungho-1
Study First Received: June 13, 2011
Results First Received: March 11, 2012
Last Updated: August 30, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Gangnam Severance Hospital:
type II diabetes
Gastric cancer
Long limb Roux-en Y

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Stomach Neoplasms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 15, 2014