Gastric Cancer With Metabolic Syndrome or Metabolic DiseaseNCT01714622
Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance
An observational study of Gastric Cancer With Metabolic Syndrome or Metabolic Disease, run by Yonsei University at 3 sites in South Korea.
Trial summary
Gastric cancer is still one of the most common malignance in Korea. Because of the popularity of regular check ups, early detection of gastric cancer has increased, consequently, the survival of the patients also has increased. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer With Metabolic Syndrome or Metabolic Disease
- What is being tested?
- subtotal gastrectomy with gastroduodenostomy, subtotal gastrectomy with Roux-en-Y gastrojejunostomy, and total gastrectomy with Rou-en-Y esophagojejunostomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Oct 2012to Oct 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: in plan to underwent curative gastrectomy for gastric cancer
Who may be able to join
- gastric cancer,
- in plan for gastrectomy for gastric cancer
- ages between 20 to 85 years old
- assign in consent
Who cannot join
- vulnerable subject (pregnant, be devoid of mental capacity, soldiers, or medical students)
- had low performance scale due to severe cardiovascular disease.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Department of Surgery, Yonsei University Colleage of Medicine,
Seoul, 120-752
Ji Yeong An
Seoul, 120-752
Sevrance hospital, Department of General surgery
Seoul, 120-752
About this study
Gastric cancer is still one of the most common malignance in Korea. Because of the popularity of regular check ups, early detection of gastric cancer has increased, consequently, the survival of the patients also has increased. In this reason, the interest of outcomes after gastrectomy for gastric cancer move survival only to quality of life of these patients.
Although the definition of metabolic syndrome is various, but it is normally accepted as a state that insulin resistance or glucose intolerance combined with hypertension or hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the treatment is modification of life style, weight loss and medication. However, in most of the patients metabolic syndrome is considered not curable disease. Recent studies have shown that some bariatric surgery offers not only control the overweight but also metabolic syndrome. The exact mechanism is still unknown but decreased gastric volume and intestinal bypass itself seemed to play an important role to improve metabolic syndrome over just decreased weight.
Read more
For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy, esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead decreased gastric volume and/or intestinal bypass, which means this operation could lead similar effect of bariatric surgery. Already, there have been several retrospective reports that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no prospective study about this subject yet in Korea.
The purpose of this study is that evaluating the degree of improvement of metabolic syndrome after gastrectomy for gastric cancer, and analyze the differences between the type of operation.
- Being tested
- subtotal gastrectomy with gastroduodenostomy, subtotal gastrectomy with Roux-en-Y gastrojejunostomy,, total gastrectomy with Rou-en-Y esophagojejunostomy
- Keywords
- metabolic syndrome, insulin resistance, gastric cancer
- Medical subject headings
- Metabolic Diseases, Metabolic Syndrome, Insulin Resistance, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subtotal gastrectomy with gastroduodenostomyProcedure or surgery
subtotal gastrectomy with Roux-en-Y gastrojejunostomy,Procedure or surgery
total gastrectomy with Rou-en-Y esophagojejunostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| metabolic syndrome | gastric cancer patients with metabolic syndrome Receives: Procedure: subtotal gastrectomy with gastroduodenostomy; Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,; Procedure: total gastrectomy with Rou-en-Y esophagojejunostomy | |
| metabolic disease | gastric cancer patients with metabolic disease Receives: Procedure: subtotal gastrectomy with gastroduodenostomy; Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,; Procedure: total gastrectomy with Rou-en-Y esophagojejunostomy | |
| normal | gastric cancer patients without metabolic syndrome or metabolic disease Receives: Procedure: subtotal gastrectomy with gastroduodenostomy; Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,; Procedure: total gastrectomy with Rou-en-Y esophagojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of metabolic syndrome
Measured: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
Secondary outcomes (1)
the changes of insulin resistance after gastrectomy
Measured: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: Canceled study due to delay of progress procedure and failure to obtain research funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer With Metabolic Syndrome or Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714622
- Sponsor's protocol ID
- 4-2012-0550
- Status last verified
- Sep 2015
- First submitted
- 17 Oct 2012
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance
- ClinicalTrials.gov ID
- NCT01714622
- Acronym / sponsor ID
- 4-2012-0550
- Keywords
- metabolic syndrome, insulin resistance, gastric cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Canceled study due to delay of progress procedure and failure to obtain research funds.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 26 Oct 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.
Gastric cancer is still one of the most common malignance in Korea. Because of the popularity of regular check ups, early detection of gastric cancer has increased, consequently, the survival of the patients also has increased. In this reason, the interest of outcomes after gastrectomy for gastric cancer move survival only to quality of life of these patients.
Although the definition of metabolic syndrome is various, but it is normally accepted as a state that insulin resistance or glucose intolerance combined with hypertension or hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the treatment is modification of life style, weight loss and medication. However, in most of the patients metabolic syndrome is considered not curable disease. Recent studies have shown that some bariatric surgery offers not only control the overweight but also metabolic syndrome. The exact mechanism is still unknown but decreased gastric volume and intestinal bypass itself seemed to play an important role to improve metabolic syndrome over just decreased weight.
For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy, esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead decreased gastric volume and/or intestinal bypass, which means this operation could lead similar effect of bariatric surgery. Already, there have been several retrospective reports that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no prospective study about this subject yet in Korea.
The purpose of this study is that evaluating the degree of improvement of metabolic syndrome after gastrectomy for gastric cancer, and analyze the differences between the type of operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metabolic syndrome | – | Procedure: subtotal gastrectomy with gastroduodenostomy, Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,, Procedure: total gastrectomy with Rou-en-Y esophagojejunostomygastric cancer patients with metabolic syndrome |
| metabolic disease | – | Procedure: subtotal gastrectomy with gastroduodenostomy, Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,, Procedure: total gastrectomy with Rou-en-Y esophagojejunostomygastric cancer patients with metabolic disease |
| normal | – | Procedure: subtotal gastrectomy with gastroduodenostomy, Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,, Procedure: total gastrectomy with Rou-en-Y esophagojejunostomygastric cancer patients without metabolic syndrome or metabolic disease |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in plan to underwent curative gastrectomy for gastric cancer
Key inclusion criteria (4 listed)
- gastric cancer,
- in plan for gastrectomy for gastric cancer
- ages between 20 to 85 years old
- assign in consent
Key exclusion criteria (2 listed)
- vulnerable subject (pregnant, be devoid of mental capacity, soldiers, or medical students)
- had low performance scale due to severe cardiovascular disease.
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 |
|---|---|---|
| subtotal gastrectomy with gastroduodenostomy | Procedure or surgery | metabolic disease, metabolic syndrome, normal |
| subtotal gastrectomy with Roux-en-Y gastrojejunostomy, | Procedure or surgery | metabolic disease, metabolic syndrome, normal |
| total gastrectomy with Rou-en-Y esophagojejunostomy | Procedure or surgery | metabolic disease, metabolic syndrome, normal |
Primary outcome
the changes of metabolic syndrome
Time frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
1 secondary outcome
the changes of insulin resistance after gastrectomy
Time frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Related trials for Gastric Cancer With Metabolic Syndrome or Metabolic Disease
Active, not recruitingObservational study
Biological Sample Repository for Gastrointestinal Disorders
Obesity, Obesity, Morbid
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer With Metabolic Syndrome or Metabolic Disease, run by Yonsei University at 3 sites 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
the changes of metabolic syndrome (time frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy). 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 29 Mar 2019.