Distal PancreatectomyNCT03314337
Pancreatic Stent for Distal Pancreatectomy
A study testing Pancreatic stent: PSOF COOK® in people with Distal Pancreatectomy, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Pancreatectomy
- What is being tested?
- Pancreatic stent: PSOF COOK®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing distal pancreatectomy
- Signed the informed consents
Who cannot join
- Recurrence patients
- pre-operative anti-cancer treatment
- patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
- AJCC stage IV
- pre operative oddi'ssphincter incision
- operation non radical
- pancreatic stent not at place
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Study Comparing Outcomes of Distal Pancreatectomy With or Without Pancreatic Stent
The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent
- Conditions
- Distal Pancreatectomy
- Being tested
- Pancreatic stent: PSOF COOK®
- Keywords
- Distal Pancreatectomy, Pancreatic stent, Post-operative pancreatic fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic stent: PSOF COOK®Device
After removing the distal pancreas, PSOF COOK will be place in the main pancreatic duct
| Study group | Role | What they receive |
|---|---|---|
| Distal Pancreatectomy without pancreatic stent | No intervention | Not described |
| Distal Pancreatectomy with pancreatic stent | Experimental | pancreatic stent will be placed in the main pancreatic duct during the operation Receives: Device: Pancreatic stent: PSOF COOK® |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality / complications
mortality, pancreatic fistula, Biliary fistula，bleeding， etc
Measured: Hospitalization 30days（duration of hospital stay)
Secondary outcomes (1)
all-cause mortality / complications
mortality, pancreatic fistula, Biliary fistula，bleeding， etc
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal PancreatectomyStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weishen WANG, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314337
- Sponsor's protocol ID
- HBP-RCT-002
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2017
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Comparing Outcomes of Distal Pancreatectomy With or Without Pancreatic Stent
- ClinicalTrials.gov ID
- NCT03314337
- Acronym / sponsor ID
- HBP-RCT-002
- Conditions
- Distal Pancreatectomy
- Keywords
- Distal Pancreatectomy, Pancreatic stent, Post-operative pancreatic fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Oct 2017 (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.
The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal Pancreatectomy without pancreatic stent | No intervention | – |
| Distal Pancreatectomy with pancreatic stent | Experimental | Device: Pancreatic stent: PSOF COOK®pancreatic stent will be placed in the main pancreatic duct during the operation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing distal pancreatectomy
- Signed the informed consents
Key exclusion criteria (7 listed)
- Recurrence patients
- pre-operative anti-cancer treatment
- patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
- AJCC stage IV
- pre operative oddi'ssphincter incision
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 |
|---|---|---|
| Pancreatic stent: PSOF COOK®After removing the distal pancreas, PSOF COOK will be place in the main pancreatic duct | Device | Distal Pancreatectomy with pancreatic stent |
Primary outcome
all-cause mortality / complications
Time frame: Hospitalization 30days（duration of hospital stay)
mortality, pancreatic fistula, Biliary fistula，bleeding， etc
1 secondary outcome
all-cause mortality / complications
Time frame: 30 days 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 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Distal Pancreatectomy
RecruitingObservational study
Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy
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Not yet recruitingObservational study
European Appleby Registry for Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Cyst of Pancreas, Pancreatectomy
Not yet recruitingPhase 1
GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy
Pancreatic Cancer, Pancreatic Adenocarcinoma
Active, not recruitingObservational study
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
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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?
A study testing Pancreatic stent: PSOF COOK® in people with Distal Pancreatectomy, run by Ruijin 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 2 inclusion and 7 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 17 Oct 2023. 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?
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?
all-cause mortality / complications (time frame: Hospitalization 30days（duration of hospital stay)). 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 Oct 2023.