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

Pancreatic Cancer Clinical Trial

Official title:

Endoscopic Pancreatic Duct Stenting for Relief of Obstructive Pain in Patients: A Prospective Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01895790
• Other study ID #: NA_00080955
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: July 5, 2013
• Last updated: March 2, 2017
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Pancreatic Duct Stent Placement

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	Complications (Safety)	Related complications within 30 days of endoscopic therapy will be recorded.	6 months
Secondary	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	6 months
Secondary	Pain free duration	Defined as pain free days after procedure. This will also be defined prior to the procedure.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Intervention time	Time required from introduction of the upper endoscope until placement of the PD stent.	Intra-procedural
Secondary	Technical success	Success of stent placement in the desired location as determined endoscopically and radiographically.	Intra-procedural
Secondary	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.	6 months
Secondary	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	6 months
Secondary	Need for surgery	Any need for operation after endoscopic therapy.	6 months
Secondary	Survival	Patient's survival after PD stenting	6 months