Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pancreatic Duct Stent Placement
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Pancreatic Duct, Stent, Pancreatic Duct Stent, Cancer, Pain, Obstructive Pain, Palliative
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pancreatic Duct
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Complications (Safety)
Related complications within 30 days of endoscopic therapy will be recorded.
Secondary Outcome Measures
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
Pain free duration
Defined as pain free days after procedure. This will also be defined prior to the procedure.
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.
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.
Intervention time
Time required from introduction of the upper endoscope until placement of the PD stent.
Technical success
Success of stent placement in the desired location as determined endoscopically and radiographically.
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.
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
Need for surgery
Any need for operation after endoscopic therapy.
Survival
Patient's survival after PD stenting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01895790
Brief Title
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer
Official Title
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients: A Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
We could not find any candidate eligible for recruitment
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Pancreatic Duct, Stent, Pancreatic Duct Stent, Cancer, Pain, Obstructive Pain, Palliative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pancreatic Duct
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pancreatic Duct Stent Placement
Primary Outcome Measure Information:
Title
Abdominal pain severity score (Efficacy)
Description
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
Time Frame
6 months
Title
Complications (Safety)
Description
Related complications within 30 days of endoscopic therapy will be recorded.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain relief
Description
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
Time Frame
6 months
Title
Pain free duration
Description
Defined as pain free days after procedure. This will also be defined prior to the procedure.
Time Frame
6 months
Title
Quality of life (QOL)
Description
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.
Time Frame
6 months
Title
Opioid dose
Description
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.
Time Frame
6 months
Title
Intervention time
Description
Time required from introduction of the upper endoscope until placement of the PD stent.
Time Frame
Intra-procedural
Title
Technical success
Description
Success of stent placement in the desired location as determined endoscopically and radiographically.
Time Frame
Intra-procedural
Title
Patency of PD stenting
Description
Determine PD patency which is defined as time period between stent placement and need for re-intervention due to stent obstruction or stent migration.
Time Frame
6 months
Title
Post-ERCP pancreatitis
Description
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
Time Frame
6 months
Title
Need for surgery
Description
Any need for operation after endoscopic therapy.
Time Frame
6 months
Title
Survival
Description
Patient's survival after PD stenting
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouen Khashab, MD
Organizational Affiliation
Johns Hopkins Hospital Department of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer
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