Status:
WITHDRAWN
Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer
Lead Sponsor:
Johns Hopkins University
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01895790
Start Date
July 1 2014
End Date
May 1 2016
Last Update
March 6 2017
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287