Pancreatic CancerPhase 1/2NCT01895790
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer
A Phase 1/2 study testing Pancreatic Duct Stent Placement in people with Pancreatic Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to assess the effects of pancreatic duct stenting on relief of obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Pancreatic Duct Stent Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2016
- Phase
- Phase 1/2
- 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
- Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer unresectable pancreatic cancer can be due 1) distant metastasis, 2) involvement of superior mesenteric artery or celiac artery, or 3) if the patient was unfit for surgery due to severe concomitant illness.
- Significant biliary obstruction presenting for ERCP.
- Significant obstructive-type abdominal pain despite use of opioid analgesics. Obstructive-pain is defined as abdominal pain that is intensified after food intake in the setting of dilated upstream pancreatic duct (>4mm in diameter).
- Ability to give informed consent.
Who cannot join
- Unable to give informed consent
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Estimated life expectancy of 4 weeks or less
- Malignant infiltration of the papilla as determined endoscopically or radiographically
- Serum bilirubin level ≥ 2 mg/dl (to avoid a confounding variable with respect to the impact of PD stenting on the pain severity and the quality of life; concomitant biliary obstruction should be managed successfully before enrollment)
- Acute gastrointestinal bleeding
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- Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients: A Prospective Pilot Study
This research is being done to assess the effects of pancreatic duct stenting on relief of obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by pancreatic cancer.
Read the detailed description
Although most people with pancreatic cancer (80-85%) suffer distressing pain, it is poorly controlled. Currently, medical management has been focused on frequent use of opioid painkillers (narcotics) which are associated with several complications. Pain in pancreatic cancer is mainly caused by tumor invasion to nerves near pancreatic gland, but in certain patients with pancreatic cancer, pain is believed to be obstructive in nature and is due to outflow obstruction of main pancreatic duct (PD) which extracts pancreatic secretions. This kind of pain is specifically marked by pain occurring after eating. With this respect, decompression of pancreatic duct has been associated with pain relief in people with chronic inflammation of pancreas due to obstruction of its main duct (chronic pancreatitis). Therefore; we think that it might be beneficial in the management of obstructive pain in people with pancreatic cancer.
Endoscopic stenting of pancreatic duct is a way for decompression and appears to be effective and safe palliative (pain relief) treatment for pain management in patients with chronic pancreatitis. Besides safety, pancreatic stenting seems to be associated with a significant decrease in amount of required opioids and analgesic drugs (and their side effects) for pain management, and may improve patients' quality of life. There are only a few old reports about beneficial effects of endoscopic pancreatic duct decompression for relief of obstructive pain in pancreatic cancer. Currently, we have improved stents. Since prior clinical practice has shown that pain improves, we plan to place stents with the expectation that pain will improve. We hope that it will decrease need for recurrent hospitalizations for pain control and decrease in need for medications (narcotics) and medication side effects, and also will improve the quality of life. Specific instruments will be applied as research tools to monitor pain score and quality of life before and after pancreatic duct stenting in this study.
- Conditions
- Pancreatic Cancer
- Being tested
- Pancreatic Duct Stent Placement
- Keywords
- Pancreatic Cancer, Pancreatic Duct, Stent, Pancreatic Duct Stent, Cancer, Pain, Obstructive Pain, Palliative
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic Duct Stent PlacementDevice
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Duct | Experimental | Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer complaining of pain due to pancreatic duct obstruction will receive a pancreatic duct stent. Receives: Device: Pancreatic Duct Stent Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain severity score (Efficacy)
The severity of abdominal pain assessed by visual Analog Scale (VAS) score ranging from 0 (no pain)-10 (the most severe pain). This will be measured at baseline (before procedure), and at 1 week, 4 weeks, 12 weeks, and 6 months after procedure
Measured: 6 months
Complications (Safety)
Related complications within 30 days of endoscopic therapy will be recorded.
Measured: 6 months
Secondary outcomes (10)
Pain relief
Categorized as: ''complete pain relief,'': the patient has no residual pain; ''major pain relief,'': the patient still experiences weak or occasional episodes of pain, with a maximum of 3 of 10 on the pain scale, or a reduction by at least 3 points on the same scale compared with before the procedure; and ''absence of pain relief,'': there is only minor or no improvement of the pain pattern
Measured: 6 months
Pain free duration
Defined as pain free days after procedure. This will also be defined prior to the procedure.
Measured: 6 months
Quality of life (QOL)
Determine improvement in QOL of patients after PD stenting. QOL will be assessed using a specific instrument for patients with pancreatic cancer, the EORTC-QLQ-Pan26 instrument, at baseline, 4 and 12 weeks and 6 months after procedure.
Measured: 6 months
Opioid dose
Required opioids dose will be documented before and 1, 4, and 12 weeks after procedure. Both scheduled and PRN (as needed) doses will be recorded before and after procedure. Dose adjustment will be carried as per standard clinical practice.
Measured: 6 months
Intervention time
Time required from introduction of the upper endoscope until placement of the PD stent.
Measured: Intra-procedural
Technical success
Success of stent placement in the desired location as determined endoscopically and radiographically.
Measured: Intra-procedural
Patency of PD stenting
Determine PD patency which is defined as time period between stent placement and need for re-intervention due to stent obstruction or stent migration.
Measured: 6 months
Post-ERCP pancreatitis
The severity of pancreatitis will be classified according to Cotton's criteria as: mild if additional hospitalization for 1-3 d is required; moderate if additional hospitalization for 4-10 day is required; and severe if hospitalization for more than 10 d is needed, as well as in cases of hemorrhagic pancreatitis, phlegmon, or pseudocyst
Measured: 6 months
Need for surgery
Any need for operation after endoscopic therapy.
Measured: 6 months
Survival
Patient's survival after PD stenting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: We could not find any candidate eligible for recruitment
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 Johns Hopkins UniversityThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouen Khashab, Johns Hopkins University
- Investigators
- Mouen Khashab, MD, Principal investigator, Johns Hopkins Hospital Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895790
- Sponsor's protocol ID
- NA_00080955
- Status last verified
- Mar 2017
- First submitted
- 5 Jul 2013
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT01895790
- Acronym / sponsor ID
- NA_00080955
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Pancreatic Duct, Stent, Pancreatic Duct Stent, Cancer, Pain, Obstructive Pain, Palliative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We could not find any candidate eligible for recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Jul 2013 (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.
This research is being done to assess the effects of pancreatic duct stenting on relief of obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by pancreatic cancer.
Detailed description
Although most people with pancreatic cancer (80-85%) suffer distressing pain, it is poorly controlled. Currently, medical management has been focused on frequent use of opioid painkillers (narcotics) which are associated with several complications. Pain in pancreatic cancer is mainly caused by tumor invasion to nerves near pancreatic gland, but in certain patients with pancreatic cancer, pain is believed to be obstructive in nature and is due to outflow obstruction of main pancreatic duct (PD) which extracts pancreatic secretions. This kind of pain is specifically marked by pain occurring after eating. With this respect, decompression of pancreatic duct has been associated with pain relief in people with chronic inflammation of pancreas due to obstruction of its main duct (chronic pancreatitis). Therefore; we think that it might be beneficial in the management of obstructive pain in people with pancreatic cancer.
Endoscopic stenting of pancreatic duct is a way for decompression and appears to be effective and safe palliative (pain relief) treatment for pain management in patients with chronic pancreatitis. Besides safety, pancreatic stenting seems to be associated with a significant decrease in amount of required opioids and analgesic drugs (and their side effects) for pain management, and may improve patients' quality of life. There are only a few old reports about beneficial effects of endoscopic pancreatic duct decompression for relief of obstructive pain in pancreatic cancer. Currently, we have improved stents. Since prior clinical practice has shown that pain improves, we plan to place stents with the expectation that pain will improve. We hope that it will decrease need for recurrent hospitalizations for pain control and decrease in need for medications (narcotics) and medication side effects, and also will improve the quality of life. Specific instruments will be applied as research tools to monitor pain score and quality of life before and after pancreatic duct stenting in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Duct | Experimental | Device: Pancreatic Duct Stent PlacementConsecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer complaining of pain due to pancreatic duct obstruction will receive a pancreatic duct stent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer unresectable pancreatic cancer can be due 1) distant metastasis, 2) involvement of superior mesenteric artery or celiac artery, or 3) if the patient was unfit for surgery due to severe concomitant illness.
- Significant biliary obstruction presenting for ERCP.
- Significant obstructive-type abdominal pain despite use of opioid analgesics. Obstructive-pain is defined as abdominal pain that is intensified after food intake in the setting of dilated upstream pancreatic duct (>4mm in diameter).
- Ability to give informed consent.
Key exclusion criteria (9 listed)
- Unable to give informed consent
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Estimated life expectancy of 4 weeks or less
- Malignant infiltration of the papilla as determined endoscopically or radiographically
- Serum bilirubin level ≥ 2 mg/dl (to avoid a confounding variable with respect to the impact of PD stenting on the pain severity and the quality of life; concomitant biliary obstruction should be managed successfully before enrollment)
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 Duct Stent Placement | Device | Pancreatic Duct |
Primary outcome
Abdominal pain severity score (Efficacy)
Time frame: 6 months
The severity of abdominal pain assessed by visual Analog Scale (VAS) score ranging from 0 (no pain)-10 (the most severe pain). This will be measured at baseline (before procedure), and at 1 week, 4 weeks, 12 weeks, and 6 months after procedure
Complications (Safety)
Time frame: 6 months
Related complications within 30 days of endoscopic therapy will be recorded.
10 secondary outcomes
Pain relief
Time frame: 6 months
Pain free duration
Time frame: 6 months
Quality of life (QOL)
Time frame: 6 months
Opioid dose
Time frame: 6 months
Intervention time
Time frame: Intra-procedural
Technical success
Time frame: Intra-procedural
Patency of PD stenting
Time frame: 6 months
Post-ERCP pancreatitis
Time frame: 6 months
Need for surgery
Time frame: 6 months
Survival
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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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.
Mouen Khashab, MD principal investigator
Johns Hopkins Hospital Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pancreatic Duct Stent Placement in people with Pancreatic Cancer, run by Johns Hopkins University at 1 site in United States.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 6 Mar 2017. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Abdominal pain severity score (Efficacy) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 6 Mar 2017.