Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus
NCT ID: NCT01375738
Last Updated: 2012-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2011-07-31
2014-05-31
Brief Summary
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Detailed Description
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* To investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes
* To investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods
* To evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes
Contents:
* Evaluation of the status of diabetes in gastric cancer patients with DM after gastrectomy
* Comparison of two reconstruction types after gastrectomy Bypass duodenum and upper jejunum: Roux-en-Y gastrojejunostomy Preservation of duodenal passage: Gastroduodenostomy
* Analysis for biochemical markers reflecting diabetic status: fasting glucose, postprandial 2h glucose, HbA1c, C-peptide, lipid profile
* Correlation of parameters associated with diabetes and GI hormones
* Measurement of GI hormones which have an effect on glucose tolerance
* Insulin, glucagon, IGF-1, GLP-1, Neuropeptide Y, Ghrelin, Leptin
* Correlation of reconstruction methods, parameters of diabetes and GI hormone levels
* Evaluation of mechanism of Roux-en-Y gastrojejunostomy on controlling diabetes
* Evaluation of Feasibility of Roux-en-Y gastrojejunostomy in gastric cancer surgery in patients with DM
* Degree of high blood glucose control, the amount of antidiabetic medication, costs for DM treatment, quality of life assessment
* Analysis for the mechanism of gastrointestinal physiology to diabetes control
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gastroduodenostomy
Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer
Gastroduodenostomy
After subtotal gastrectomy with lymph node dissection, the gastric remnant is anastomosed to duodenum 1st portion with circular or linear staplers and the artificial lesser curvature is repaired with linear stapler.
Roux-en Y gastrojejunostomy
Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer
Roux-en Y gastrojejunostomy
After subtotal gastrectomy with lymph node dissection, the jejunum is transected 25\~30cm distal to the ligament of Treitz. Distal jejunum is drawn up and sutured to the gastric remnant and the proximal jejunum is anastomosed to the distal jejunum at 30\~40cm from the new gastric-jejunal junction.
Interventions
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Roux-en Y gastrojejunostomy
After subtotal gastrectomy with lymph node dissection, the jejunum is transected 25\~30cm distal to the ligament of Treitz. Distal jejunum is drawn up and sutured to the gastric remnant and the proximal jejunum is anastomosed to the distal jejunum at 30\~40cm from the new gastric-jejunal junction.
Gastroduodenostomy
After subtotal gastrectomy with lymph node dissection, the gastric remnant is anastomosed to duodenum 1st portion with circular or linear staplers and the artificial lesser curvature is repaired with linear stapler.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed gastric adenocarcinoma located lower one third of stomach
* Postoperative confirmed pT1N0, pT2N0, pT1N1
* Informed consent
Exclusion Criteria
* Preoperative uncontrolled serious comorbidity
* Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.)
* Patient who experience any complications requiring reoperation following gastrectomy
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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ji yeong an
assistant professor
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Facility Contacts
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Ji Yeong An, MD
Role: primary
Yoo-Min Kim, MD
Role: backup
References
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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.
Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
Other Identifiers
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4-2011-0109
Identifier Type: -
Identifier Source: org_study_id