Safety and Efficacy of Long Limb Roux-en Y Reconstruction

NCT01373346 | Completed Results DMC

• 1 other identifier: seungho-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2 in Nonobese; Gastric Cancer

Keywords

type II diabetes; Gastric cancer; Long limb Roux-en Y

Outcome Measures

Primary Outcomes (5)

• Morbidity

  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

  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

  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

  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

  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 Outcomes (13)

• Matsuda Index

  Before operation , 6 months after operation, Until end of study (on average 14.8 months)

• QUICKI

  Before operation , 6 months after operation , Until end of study (on average 14.8 months)

• HOMA-IR

  Before operation , 6 months after operation, Until end of study (on average 14.8 months)

• HOMA-B

  Before operation , 6 months after operation, Until end of study (on average 14.8 months)

• Body Mass Index

  Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)

Study Arms (1)

Long limb Roux-en Y reconstruction

EXPERIMENTAL

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

Interventions

Long limb Roux-en Y reconstruction PROCEDURE

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

Also known as: modified Roux-en Y

Long limb Roux-en Y reconstruction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• Anti-GAD antibody (-), Anti-islet antibody (-)
• C-peptide level: above 1ng/ml

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangNam Severance Hospital

Seoul, 146-92, South Korea

Location

Related Publications (18)

• Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.

  PMID: 19272486 BACKGROUND

• Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.

  PMID: 7677463 BACKGROUND

• Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, Zimmet P, Son HY. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006 Nov 11;368(9548):1681-8. doi: 10.1016/S0140-6736(06)69703-1.

  PMID: 17098087 BACKGROUND

• FRIEDMAN MN, SANCETTA AJ, MAGOVERN GJ. The amelioration of diabetes mellitus following subtotal gastrectomy. Surg Gynecol Obstet. 1955 Feb;100(2):201-4. No abstract available.

  PMID: 13238177 BACKGROUND

• ANGERVALL L, DOTEVALL G, TILLANDER H. Amelioration of diabetes mellitus following gastric resection. Acta Med Scand. 1961 Jun;169:743-8. doi: 10.1111/j.0954-6820.1961.tb07885.x. No abstract available.

  PMID: 13683582 BACKGROUND

• Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30.

  PMID: 20863527 BACKGROUND

• Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49.

  PMID: 22228970 BACKGROUND

• DeFronzo RA, Matsuda M. Reduced time points to calculate the composite index. Diabetes Care. 2010 Jul;33(7):e93. doi: 10.2337/dc10-0646. No abstract available.

  PMID: 20587713 BACKGROUND

• Emoto M, Nishizawa Y, Maekawa K, Hiura Y, Kanda H, Kawagishi T, Shoji T, Okuno Y, Morii H. Homeostasis model assessment as a clinical index of insulin resistance in type 2 diabetic patients treated with sulfonylureas. Diabetes Care. 1999 May;22(5):818-22. doi: 10.2337/diacare.22.5.818.

  PMID: 10332688 BACKGROUND

• Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661.

  PMID: 10902785 BACKGROUND

• Frenken M, Cho EY, Karcz WK, Grueneberger J, Kuesters S. Improvement of type 2 diabetes mellitus in obese and non-obese patients after the duodenal switch operation. J Obes. 2011;2011:860169. doi: 10.1155/2011/860169. Epub 2011 Mar 3.

  PMID: 21461399 BACKGROUND

• Navarrete SA, Leyba JL, Llopis SN. Laparoscopic sleeve gastrectomy with duodenojejunal bypass for the treatment of type 2 diabetes in non-obese patients: technique and preliminary results. Obes Surg. 2011 May;21(5):663-7. doi: 10.1007/s11695-011-0371-8.

  PMID: 21336559 BACKGROUND

• Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006 May-Jun;2(3):401-4, discussion 404. doi: 10.1016/j.soard.2006.02.011.

  PMID: 16925363 BACKGROUND

• DePaula AL, Macedo AL, Mota BR, Schraibman V. Laparoscopic ileal interposition associated to a diverted sleeve gastrectomy is an effective operation for the treatment of type 2 diabetes mellitus patients with BMI 21-29. Surg Endosc. 2009 Jun;23(6):1313-20. doi: 10.1007/s00464-008-0156-x. Epub 2008 Oct 2.

  PMID: 18830750 BACKGROUND

• Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):195-7. doi: 10.1016/j.soard.2007.01.009. No abstract available.

  PMID: 17386401 BACKGROUND

• Orci L, Chilcott M, Huber O. Short versus long Roux-limb length in Roux-en-Y gastric bypass surgery for the treatment of morbid and super obesity: a systematic review of the literature. Obes Surg. 2011 Jun;21(6):797-804. doi: 10.1007/s11695-011-0409-y.

  PMID: 21479976 BACKGROUND

• Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, Castagneto M, Marescaux J. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006 Nov;244(5):741-9. doi: 10.1097/01.sla.0000224726.61448.1b.

  PMID: 17060767 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

One mortality due to early recurrence leading to reduced number of subject analyzed.

Results Point of Contact

• Title: Seung Ho Choi, M.D., Ph.D.
• Organization: Gangnam severance hospital

choish@yuhs.ac

82-2-2019-3374

Study Officials

• Seung Ho Choi, M.D., Ph.D.

  Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of surgery

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 14, 2011
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 3, 2012
• Results First Posted: August 31, 2012

Record last verified: 2012-08

Locations

KR (1)