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Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus

The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01375738
Enrollment
40
Registered
2011-06-17
Start date
2011-07-31
Completion date
2014-05-31
Last updated
2012-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gastric Cancer

Keywords

Early gastric cancer

Brief summary

This study is 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, and to evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes.

Detailed description

Purpose: * 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

Interventions

PROCEDURERoux-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.

PROCEDUREGastroduodenostomy

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patient who are older than 20 years and younger than 80 years * Histologically confirmed gastric adenocarcinoma located lower one third of stomach * Postoperative confirmed pT1N0, pT2N0, pT1N1 * Informed consent

Exclusion criteria

* Previous history of treatment for other malignancy or inflammatory disease * Preoperative uncontrolled serious comorbidity * Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.) * Patient who experience any complications requiring reoperation following gastrectomy

Design outcomes

Primary

MeasureTime frameDescription
Blood sugar stabilization after gastrectomythree months after surgeryBy comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026