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

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Diabetes Mellitus Type 2 in Nonobese; Gastric Cancer

Treatments: Procedure: Long limb Roux-en Y reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01373346

seungho-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Long limb Roux-en Y reconstruction

Experimental group

Description:

Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.

Treatment:

Procedure: Long limb Roux-en Y reconstruction