Postoperative FistulaPhase 2EDIDPDNCT01634971
External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)
A Phase 2 study testing Internal Drainage of Pancreatic Duct after pancreatomy in people with Postoperative Fistula and Complications of Surgical and Medical Care: General Terms, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Fistula, Complications of Surgical and Medical Care: General Terms
- What is being tested?
- Internal Drainage of Pancreatic Duct after pancreatomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Dec 2016
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years.
- Received pancreatoduodenectomy.
- Informed consent has been signed.
Who cannot join
- Age less than 18 years
- Emergency surgery
- Past history of pancreatic surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Qiang WU, MD. Ph.D., 18622221080, wuqiangtianjin@hotmail.com
Qiang WU, MD. Ph.D.
About this study
Official title: Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent
Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.
Read the detailed description
The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other surgical complications after pancreatoduodenectomy (PD).
- Being tested
- Internal Drainage of Pancreatic Duct after pancreatomy
- Keywords
- Postoperative pancreatic fistula(POPF);, Postpancreatectomy hemorrhage(PPH);, Delayed gastric emptying (DGE);, Bile leakage after pancreatic surgery;, Anastomotic leakage
- Medical subject headings
- Gastroparesis, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Drainage of Pancreatic Duct after pancreatomyProcedure or surgery
the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum.
| Study group | Role | What they receive |
|---|---|---|
| External Drainage of pancreatic duct | No intervention | External Drainage of pancreatic duct was used in PD. |
| Internal Drainage of Pancreatic Duct | Experimental | the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum. Receives: Procedure: Internal Drainage of Pancreatic Duct after pancreatomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of Postoperative pancreatic fistula within 2 weeks after operation
Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.
Measured: within 2 weeks after operation
Secondary outcomes (1)
the rate of postoperative Surgical Complications
the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage
Measured: 2 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative FistulaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang WU, MD. Ph.D., Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634971
- Sponsor's protocol ID
- CIH-WUQ-201205001
- Other IDs
- E2012010
- Acronym
- EDIDPD
- Status last verified
- Jan 2013
- First submitted
- 3 Jul 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent
- ClinicalTrials.gov ID
- NCT01634971
- Acronym / sponsor ID
- EDIDPD / CIH-WUQ-201205001
- Keywords
- Postoperative pancreatic fistula(POPF);, Postpancreatectomy hemorrhage(PPH);, Delayed gastric emptying (DGE);, Bile leakage after pancreatic surgery;, Anastomotic leakage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 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.
Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.
Detailed description
The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other surgical complications after pancreatoduodenectomy (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Drainage of pancreatic duct | No intervention | –External Drainage of pancreatic duct was used in PD. |
| Internal Drainage of Pancreatic Duct | Experimental | Procedure: Internal Drainage of Pancreatic Duct after pancreatomythe Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18 years.
- Received pancreatoduodenectomy.
- Informed consent has been signed.
Key exclusion criteria (3 listed)
- Age less than 18 years
- Emergency surgery
- Past history of pancreatic surgery.
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 |
|---|---|---|
| Internal Drainage of Pancreatic Duct after pancreatomythe Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum. | Procedure or surgery | Internal Drainage of Pancreatic Duct |
Primary outcome
the rate of Postoperative pancreatic fistula within 2 weeks after operation
Time frame: within 2 weeks after operation
Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.
1 secondary outcome
the rate of postoperative Surgical Complications
Time frame: 2 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
Qiang WU, MD. Ph.D. study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Internal Drainage of Pancreatic Duct after pancreatomy in people with Postoperative Fistula and Complications of Surgical and Medical Care: General Terms, run by Tianjin Medical University Cancer Institute and Hospital 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 3 inclusion and 3 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 17 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Qiang WU, MD. Ph.D. (18622221080, wuqiangtianjin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of Postoperative pancreatic fistula within 2 weeks after operation (time frame: within 2 weeks after operation). 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 17 Feb 2016.