Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatment pancreatic duct stent placement
Phase phase 1/phase 2
Sponsor Johns Hopkins University
Start date July 2014
End date July 2017
Trial size 10 participants
Trial identifier NCT01895790, NA_00080955

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(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.
pancreatic duct stent placement

Primary Outcomes

Measure
Abdominal pain severity score (Efficacy)
time frame: 6 months
Complications (Safety)
time frame: 6 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients: A Prospective Pilot Study
Principal investigator Mouen Khashab, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.