Early Gastric CancerNCT01643811
Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients
An observational study of Early Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- gastrectomy and Endoscopic submucosal dissection
- Type of treatment
- Surgery or procedure
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed as early gastric cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
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.
- Conditions
- Early Gastric Cancer
- Being tested
- gastrectomy, Endoscopic submucosal dissection
- Keywords
- early gastric cancer, diabetes, hypertension
- Medical subject headings
- Stomach Neoplasms, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrectomyProcedure or surgery
subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy
Endoscopic submucosal dissectionProcedure or surgery
endoscopic submucosal dissection
| Study group | Role | What they receive |
|---|---|---|
| Gastrectomy | Patients who underwent gastrectomy for early gastric cancer Receives: Procedure: gastrectomy | |
| Endoscopic submucosal dissection | Patients who underwent endoscopic submucosal dissection for early gastric cancer Receives: Procedure: Endoscopic submucosal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy
Measured: 5 years after operation
difference of proportion of patients who quit previous medication for diabetes according to anastomosis
difference of proportion of patients who quit previous medication for diabetes among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy
Measured: 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
difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy
Measured: 5 years after operation
difference of proportion of patients who quit previous medication for hypertension according to anastomosis
difference of proportion of patients who quit previous medication for hypertension among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy
Measured: 5 years after operation
difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation
difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation in patients with diabetes
Measured: 1 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Keun Won Ryu, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643811
- Sponsor's protocol ID
- 1210552-1
- Status last verified
- Mar 2016
- First submitted
- 11 Jul 2012
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT01643811
- Acronym / sponsor ID
- 1210552-1
- Conditions
- Early Gastric Cancer
- Keywords
- early gastric cancer, diabetes, hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Apr 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrectomy | – | Procedure: gastrectomyPatients who underwent gastrectomy for early gastric cancer |
| Endoscopic submucosal dissection | – | Procedure: Endoscopic submucosal dissectionPatients who underwent endoscopic submucosal dissection for early gastric cancer |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed as early gastric cancer
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrectomysubtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy | Procedure or surgery | Gastrectomy |
| Endoscopic submucosal dissectionendoscopic submucosal dissection | Procedure or surgery | Endoscopic submucosal dissection |
Primary outcome
Proportion of patients who quit previous medication for diabetes because of improved disease
Time frame: 5 year after operation
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.
Proportion of patients who quit previous medication for hypertension because of improved disease
Time frame: 5 years after operation
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 secondary outcomes
difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy
Time frame: 5 years after operation
difference of proportion of patients who quit previous medication for diabetes according to anastomosis
Time frame: 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
Time frame: 5 years after operation
difference of proportion of patients who quit previous medication for hypertension according to anastomosis
Time frame: 5 years after operation
difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation
Time frame: 1 years after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who quit previous medication for diabetes because of improved disease (time frame: 5 year after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.