NCT01375738

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

May 27, 2011

Last Update Submit

September 12, 2012

Conditions

Gastric CancerDiabetes

Keywords

Early gastric cancer

Outcome Measures

Primary Outcomes (1)

  • Blood sugar stabilization after gastrectomy

    By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.

    three months after surgery

Study Arms (2)

Gastroduodenostomy

ACTIVE COMPARATOR

Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer

Procedure: Gastroduodenostomy

Roux-en Y gastrojejunostomy

EXPERIMENTAL

Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer

Procedure: Roux-en Y gastrojejunostomy

Interventions

Roux-en Y gastrojejunostomyPROCEDURE

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.

Roux-en Y gastrojejunostomy
GastroduodenostomyPROCEDURE

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.

Gastroduodenostomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (2)

  • 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: 20863527BACKGROUND

  • 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.

    PMID: 34523717DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsDiabetes Mellitus

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 17, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

May 1, 2014

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations

KR(1)