Pancreas CancerNCT00500968
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
A study testing stent and Distal pancreatectomy in people with Pancreas Cancer and Fistula, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreas Cancer, Fistula
- What is being tested?
- stent and Distal pancreatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Apr 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.
Who cannot join
- The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.
Read the detailed description
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
- Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.
- Conditions
- Pancreas Cancer, Fistula
- Being tested
- stent, Distal pancreatectomy
- Keywords
- Pancreas, Leakage, Fistula, tail
- Medical subject headings
- Pancreatic Neoplasms, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentProcedure or surgery
Also called ERCP
ERCP guided stent insertion before transection of the gland
Distal pancreatectomyProcedure or surgery
Also called surgery
conventional distal pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| Stent | Active comparator | Not described Receives: Procedure: stent |
| conventional distal pancreatectomy | Active comparator | Not described Receives: Procedure: Distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain fluid content analyses
Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.
Measured: At least 5 postoperative days
Secondary outcomes (1)
Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent
Measured: At least 5 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startNov 2006
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Urban Arnelo, Study director, Karolinksa university hospitalFarshad Frozanpor, Principal investigator, Karolinksa university hospitalLars Lundell, Professor, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500968
- Sponsor's protocol ID
- 2006/3:3
- Status last verified
- Sep 2007
- First submitted
- 12 Jul 2007
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frozanpor F, Lundell L, Segersvard R, Arnelo U. The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial. Ann Surg. 2012 Jun;255(6):1032-6. doi: 10.1097/SLA.0b013e318251610f.
PubMed 22584629
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
- ClinicalTrials.gov ID
- NCT00500968
- Acronym / sponsor ID
- 2006/3:3
- Conditions
- Pancreas Cancer, Fistula
- Keywords
- Pancreas, Leakage, Fistula, tail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Jul 2007 (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.
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.
Detailed description
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
- Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Active comparator | Procedure: stent |
| conventional distal pancreatectomy | Active comparator | Procedure: Distal pancreatectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.
Key exclusion criteria (1 listed)
- The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.
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 |
|---|---|---|
| stentAlso: ERCPERCP guided stent insertion before transection of the gland | Procedure or surgery | Stent |
| Distal pancreatectomyAlso: surgeryconventional distal pancreatectomy | Procedure or surgery | conventional distal pancreatectomy |
Primary outcome
Drain fluid content analyses
Time frame: At least 5 postoperative days
Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.
1 secondary outcome
Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent
Time frame: At least 5 postoperative days
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 7 Apr 2011.
- Derived from this study: PubMed 22584629Frozanpor F, Lundell L, Segersvard R, Arnelo U. The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial. Ann Surg. 2012 Jun;255(6):1032-6. doi: 10.1097/SLA.0b013e318251610f.
Related trials for Pancreas Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Urban Arnelo study director
Karolinksa university hospital
Farshad Frozanpor principal investigator
Karolinksa university hospital
Lars Lundell, Professor study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stent and Distal pancreatectomy in people with Pancreas Cancer and Fistula, run by Karolinska Institutet at 1 site in Sweden.
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 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: finished, as of the sponsor's last update on 7 Apr 2011. 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 Sweden. 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?
Drain fluid content analyses (time frame: At least 5 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500968, which also lists 1 linked publication.
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 7 Apr 2011.