Clinical trial NCT01895790: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Pancreatic Duct
Stent
Pancreatic Duct Stent
Cancer
Pain
Obstructive Pain
Palliative
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Abdominal pain severity score (Efficacy)
timeFrame: 6 months
measure: Complications (Safety)
timeFrame: 6 months
Secondary outcomes:
measure: Pain relief
timeFrame: 6 months
measure: Pain free duration
timeFrame: 6 months
measure: Quality of life (QOL)
timeFrame: 6 months
measure: Opioid dose
timeFrame: 6 months
measure: Intervention time
timeFrame: Intra-procedural
measure: Technical success
timeFrame: Intra-procedural
measure: Patency of PD stenting
timeFrame: 6 months
measure: Post-ERCP pancreatitis
timeFrame: 6 months
measure: Need for surgery
timeFrame: 6 months
measure: Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Hospital Department of Gastroenterology
name: Mouen Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References: