Pancreatic CancerNCT03069664
Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer
A study testing ERCP and Covered Self-expandable Metal Stent in people with Pancreatic Cancer and Pancreatic Duct Stricture, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Duct Stricture
- What is being tested?
- ERCP and Covered Self-expandable Metal Stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFinland
- Study dates
- 17 Nov 2017to Dec 2023
- 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
- Patients have inoperable pancreatic cancer.
- Pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm.
- Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 6 (Visual Analogue Scale) at the time of recruitment.
Who cannot join
- Patients are not fit enough to undergo ERCP
Trial locations and contacts
2 sites in 1 country.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, HUS, 00029
Leena Kylänpää, MD, PhD, +358504272869, leena.kylanpaa@hus.fi
Sini Vehviläinen, MD
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00029
Leena Kylänpää, leena.kylanpaa@hus.fi
About this study
Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. The study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.
Read the detailed description
In this prospective study all patients have inoperable pancreatic cancer. In these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. Patients also suffer from chronic abdominal pain caused by pancreatic cancer. The strength of the pain the patients are experiencing is evaluated with visual analogue scale (VAS). Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 4 at the time of recruitment.
In this pilot study a total of 40 patients are recruited. Patients are divided into to two 20 patient groups. First group will receive a pancreatic duct stent followed by pain medication if needed and the control group will go with conventional pain relief methods only. All patients are asked to evaluate the strength of experienced pain with visual analogue scale at the time of recruitment, and then every 4 weeks up to 24 weeks. The patients will also be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 quality of life questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. The patients are also asked to report their body weight, and the amount of pancreatic enzyme supplements needed at every point of survey.
- Conditions
- Pancreatic Cancer, Pancreatic Duct Stricture
- Being tested
- ERCP, Covered Self-expandable Metal Stent
- Keywords
- Pancreatic Cancer, Pancreatic Duct Stricture, Endoscopic treatment
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
endoscopic retrograde cholangiopancreatography
Covered Self-expandable Metal StentDevice
Pancreatic duct stent
| Study group | Role | What they receive |
|---|---|---|
| Covered Self-expandable Metal Stent | Active comparator | ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent Receives: Procedure: ERCP; Device: Covered Self-expandable Metal Stent |
| Control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in experienced quality of life
The patients will be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks.
Measured: Enquiry at recruitment and every 4 weeks up to 24 weeks
Secondary outcomes (3)
Change in experienced strength of pain in visual analogue scale
Patients evaluate the strength of pain in visual analogue scale
Measured: Enquiry at recruitment and every 4 weeks up to 24 weeks
Change in body weight
Patients report their body weight in kilograms at every point of survey.
Measured: Enquiry at recruitment and every 4 weeks up to 24 weeks
Change in need for pancreatic enzyme supplements
Patients report their need for pancreatic enzyme supplements at every point of survey
Measured: Enquiry at recruitment and every 4 weeks up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start17 Nov 2017
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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.
- More trials run by Helsinki University Central 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leena Kylanpaa, Helsinki University Central Hospital
- Investigators
- Leena Kylänpää, MD, PhD, Principal investigator, Helsinki UniversityHospitalSini M Vehviläinen, MD, Study chair, Helsinki University Central HospitalHanna Seppänen, MD, PhD, Study chair, Helsinki University Central HospitalMarianne Udd, MD, PhD, Study chair, Helsinki University Central HospitalOuti Lindström, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069664
- Sponsor's protocol ID
- Palliative pancreatic stenting
- Status last verified
- Aug 2022
- First submitted
- 19 Feb 2017
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03069664
- Acronym / sponsor ID
- Palliative pancreatic stenting
- Conditions
- Pancreatic Cancer, Pancreatic Duct Stricture
- Keywords
- Pancreatic Cancer, Pancreatic Duct Stricture, Endoscopic treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Mar 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.
Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. The study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.
Detailed description
In this prospective study all patients have inoperable pancreatic cancer. In these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. Patients also suffer from chronic abdominal pain caused by pancreatic cancer. The strength of the pain the patients are experiencing is evaluated with visual analogue scale (VAS). Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 4 at the time of recruitment.
In this pilot study a total of 40 patients are recruited. Patients are divided into to two 20 patient groups. First group will receive a pancreatic duct stent followed by pain medication if needed and the control group will go with conventional pain relief methods only. All patients are asked to evaluate the strength of experienced pain with visual analogue scale at the time of recruitment, and then every 4 weeks up to 24 weeks. The patients will also be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 quality of life questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. The patients are also asked to report their body weight, and the amount of pancreatic enzyme supplements needed at every point of survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covered Self-expandable Metal Stent | Active comparator | Procedure: ERCP, Device: Covered Self-expandable Metal StentERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent |
| Control group | No intervention | –control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients have inoperable pancreatic cancer.
- Pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm.
- Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 6 (Visual Analogue Scale) at the time of recruitment.
Key exclusion criteria (1 listed)
- Patients are not fit enough to undergo ERCP
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 |
|---|---|---|
| ERCPendoscopic retrograde cholangiopancreatography | Procedure or surgery | Covered Self-expandable Metal Stent |
| Covered Self-expandable Metal StentPancreatic duct stent | Device | Covered Self-expandable Metal Stent |
Primary outcome
Change in experienced quality of life
Time frame: Enquiry at recruitment and every 4 weeks up to 24 weeks
The patients will be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks.
3 secondary outcomes
Change in experienced strength of pain in visual analogue scale
Time frame: Enquiry at recruitment and every 4 weeks up to 24 weeks
Change in body weight
Time frame: Enquiry at recruitment and every 4 weeks up to 24 weeks
Change in need for pancreatic enzyme supplements
Time frame: Enquiry at recruitment and every 4 weeks up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Pancreatic 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.
Leena Kylänpää, MD, PhD principal investigator
Helsinki UniversityHospital
Sini M Vehviläinen, MD study chair
Helsinki University Central Hospital
Hanna Seppänen, MD, PhD study chair
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP and Covered Self-expandable Metal Stent in people with Pancreatic Cancer and Pancreatic Duct Stricture, run by Helsinki University Central Hospital at 2 sites in Finland.
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 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
Contact Leena Kylänpää, MD, PhD (+358504272869, leena.kylanpaa@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in experienced quality of life (time frame: Enquiry at recruitment and every 4 weeks up to 24 weeks). 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 16 Aug 2022.