Pancreatic FistulaNCT03822676
Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula
A study testing Prophylactic pancreatic stent in people with Pancreatic Fistula, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Prophylactic pancreatic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2019to May 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for elective segmental pancreatectomy
Who cannot join
- Subjects for whom ERCP procedures are contraindicated
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
- Age less than 18 year
- Emergency surgery
- Previous pancreatic surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Aiming Yang, M.D., +86-10-69151593, yangaiming@medmail.com.cn
Yunlu Feng, M.D.
About this study
Official title: Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy
Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.
- Conditions
- Pancreatic Fistula
- Being tested
- Prophylactic pancreatic stent
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic pancreatic stentDevice
Prophylactic pancreatic stent before segmental pancreatic surgery
| Study group | Role | What they receive |
|---|---|---|
| Stent | Experimental | Prophylactic pancreatic stent before segmental pancreatic surgery Receives: Device: Prophylactic pancreatic stent |
| No stent | No intervention | No prophylactic stent before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pancreatic fistula
Grade B and C
Measured: from postoperative day 3 to 30
Secondary outcomes (2)
Severity of pancreatic fistula
Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.
Measured: from postoperative day 3 to 30
Length of stay
Length of hospital stay
Measured: from postoperative day 1 to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start22 Jan 2019
- Primary completionDec 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822676
- Sponsor's protocol ID
- ZS-1833
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy
- ClinicalTrials.gov ID
- NCT03822676
- Acronym / sponsor ID
- ZS-1833
- Conditions
- Pancreatic Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 30 Jan 2019 (actual)
- 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) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Experimental | Device: Prophylactic pancreatic stentProphylactic pancreatic stent before segmental pancreatic surgery |
| No stent | No intervention | –No prophylactic stent before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for elective segmental pancreatectomy
Key exclusion criteria (5 listed)
- Subjects for whom ERCP procedures are contraindicated
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
- Age less than 18 year
- Emergency surgery
- Previous 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 |
|---|---|---|
| Prophylactic pancreatic stentProphylactic pancreatic stent before segmental pancreatic surgery | Device | Stent |
Primary outcome
Postoperative pancreatic fistula
Time frame: from postoperative day 3 to 30
Grade B and C
2 secondary outcomes
Severity of pancreatic fistula
Time frame: from postoperative day 3 to 30
Length of stay
Time frame: from postoperative day 1 to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic pancreatic stent in people with Pancreatic Fistula, run by Peking Union Medical College 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 1 inclusion and 5 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 30 Jan 2019. 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?
Postoperative pancreatic fistula (time frame: from postoperative day 3 to 30). 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 30 Jan 2019.