NCT01643811

Brief Summary

The purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

July 11, 2012

Last Update Submit

March 23, 2016

Conditions

Early Gastric Cancer

Keywords

early gastric cancer, diabetes, hypertension

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients who quit previous medication for diabetes because of improved disease

    proportion of patients who quit their previous medication for diabetes because of improved disease after operation among all patients who underwent gastrectomy for early gastric cancer with diabetes.

    5 year after operation

  • Proportion of patients who quit previous medication for hypertension because of improved disease

    Proportion of patients who quit previous medication for hypertension because of improved disease among the patients who diagnosed as early gastric cancer and hypertension

    5 years after operation

Secondary Outcomes (5)

  • difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy

    5 years after operation

  • difference of proportion of patients who quit previous medication for diabetes according to anastomosis

    5 year after operation

  • difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy

    5 years after operation

  • difference of proportion of patients who quit previous medication for hypertension according to anastomosis

    5 years after operation

  • difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation

    1 years after operation

Study Arms (2)

Gastrectomy

Patients who underwent gastrectomy for early gastric cancer

Procedure: gastrectomy

Endoscopic submucosal dissection

Patients who underwent endoscopic submucosal dissection for early gastric cancer

Procedure: Endoscopic submucosal dissection

Interventions

gastrectomyPROCEDURE

subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy

Gastrectomy
Endoscopic submucosal dissectionPROCEDURE

endoscopic submucosal dissection

Endoscopic submucosal dissection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients diagnosed as early gastric cancer

You may qualify if:

  • Histologically proven primary gastric adenocarcinoma
  • clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed tomography
  • aged 20-80 year old,
  • performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • diagnosed as diabetes or hypertension
  • patients planning to undergo gastrectomy or endoscopic submucosal dissection
  • written informed consent

You may not qualify if:

  • having high risk for operation such as severe heart disease, severe respiratory disease
  • pregnant
  • previous abdominal surgery or radiation therapy
  • proven more advanced disease than pathological stage II requiring adjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang, Kyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Stomach NeoplasmsDiabetes MellitusHypertension

Interventions

GastrectomyEndoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 18, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

KR(1)