Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients With Pancreatic Cancer

NCT ID: NCT01895790

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-05-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pancreatic Duct

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.

Group Type: EXPERIMENTAL

Pancreatic Duct Stent Placement

Intervention Type: DEVICE

Interventions

Pancreatic Duct Stent Placement

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Mouen Khashab

Official Title: Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mouen Khashab, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Hospital Department of Gastroenterology

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00080955

Identifier Type: -

Identifier Source: org_study_id