Pancreatic CancerNCT01926717
A Comparative Clinical Research on Single Roux-en-Y and Traditional Roux-en-Y of Pancreaticojejunostomy-choledochojejunostomy For Treatment of Obstruction of Pancreatic Duct and Bile Duct
An observational study of Pancreatic Cancer, run by Chengyi Sun at 1 site in China.
Trial summary
This study is being done to learn more about how different surgery procedures bring back the quality of life.After removing the small intestine at least 20cm in patients with pancreatic cancer, Some patients develop problems because they are disorder their digestive system, such as cramping, heartburn,vomiting. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Dec 2018
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic cancer
Who may be able to join
- Patient 30 years of age or older
- Pathologically confirmed pancreatic cancer (biopsy may be performed at our institution)
- No evidence of metastases(a)
- decide performe Roux-en-Y(b)
- single Roux-en-Y reconstruction is technically feasible(c)
- Patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. If metastatic disease is identified at the time of operation, the patient will not be randomized.
- Patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a sngle Roux-en-Y at the time of operation. If a sngle Roux-en-Y is not performed, the patient will not be randomized.
- the surgeon feels that the single Roux-en-Y is not technically feasible at the time of operation,the patients will be excluded. This may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion.
Who cannot join
- Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, 550004
Chengyi Sun, M.D, +86-0851-6771326, chengyisun@medmail.com.cn
Chengyi Sun, M.D
About this study
This study is being done to learn more about how different surgery procedures bring back the quality of life.After removing the small intestine at least 20cm in patients with pancreatic cancer, Some patients develop problems because they are disorder their digestive system, such as cramping, heartburn,vomiting.
- Conditions
- Pancreatic Cancer
- Keywords
- Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy | Not described | |
| Pancreaticoduodenectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The secretion function of the pancreas
Measured: Participants will be followed for overall 3 year after surgery
Secondary outcomes (1)
The function of biliary tract
Measured: Participants will be followed for overall 3 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startDec 2010
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengyi Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chengyi Sun, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926717
- Sponsor's protocol ID
- GYGDWK-02
- Status last verified
- Mar 2016
- First submitted
- 19 Aug 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Research on Single Roux-en-Y and Traditional Roux-en-Y of Pancreaticojejunostomy-choledochojejunostomy For Treatment of Obstruction of Pancreatic Duct and Bile Duct
- ClinicalTrials.gov ID
- NCT01926717
- Acronym / sponsor ID
- GYGDWK-02
- Conditions
- Pancreatic Cancer
- Keywords
- Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chengyi SunUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Aug 2013 (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.
This study is being done to learn more about how different surgery procedures bring back the quality of life.After removing the small intestine at least 20cm in patients with pancreatic cancer, Some patients develop problems because they are disorder their digestive system, such as cramping, heartburn,vomiting.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy | – | – |
| Pancreaticoduodenectomy | – | – |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic cancer
Key inclusion criteria (8 listed)
- Patient 30 years of age or older
- Pathologically confirmed pancreatic cancer (biopsy may be performed at our institution)
- No evidence of metastases(a)
- decide performe Roux-en-Y(b)
- single Roux-en-Y reconstruction is technically feasible(c)
Key exclusion criteria (1 listed)
- Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The secretion function of the pancreas
Time frame: Participants will be followed for overall 3 year after surgery
1 secondary outcome
The function of biliary tract
Time frame: Participants will be followed for overall 3 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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 Affiliated Hospital of Guiyang Medical College
Guiyang, China
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 Pancreatic Cancer, run by Chengyi Sun at 1 site in China.
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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The secretion function of the pancreas (time frame: Participants will be followed for overall 3 year after surgery). 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 8 Mar 2016.