Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Not Applicable

• Conditions: Pancreatic Cancer; Pancreatic Duct Stricture
• Interventions: Procedure: ERCP; Device: Covered Self-expandable Metal Stent

• Registration Number: NCT03069664
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. The study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.

Detailed Description

In this prospective study all patients have inoperable pancreatic cancer. In these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. Patients also suffer from chronic abdominal pain caused by pancreatic cancer. The strength of the pain the patients are experiencing is evaluated with visual analogue scale (VAS). Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 4 at the time of recruitment.

In this pilot study a total of 40 patients are recruited. Patients are divided into to two 20 patient groups. First group will receive a pancreatic duct stent followed by pain medication if needed and the control group will go with conventional pain relief methods only. All patients are asked to evaluate the strength of experienced pain with visual analogue scale at the time of recruitment, and then every 4 weeks up to 24 weeks. The patients will also be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 quality of life questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. The patients are also asked to report their body weight, and the amount of pancreatic enzyme supplements needed at every point of survey.

Study Timeline

• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Start: 2017-11-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients have inoperable pancreatic cancer.
• Pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm.
• Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 6 (Visual Analogue Scale) at the time of recruitment.

Exclusion Criteria

• Patients are not fit enough to undergo ERCP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Covered Self-expandable Metal Stent	ERCP	ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent
Covered Self-expandable Metal Stent	Covered Self-expandable Metal Stent	ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent

Primary Outcome Measures

Name	Time	Method
Change in experienced quality of life	Enquiry at recruitment and every 4 weeks up to 24 weeks	The patients will be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in experienced strength of pain in visual analogue scale	Enquiry at recruitment and every 4 weeks up to 24 weeks	Patients evaluate the strength of pain in visual analogue scale
Change in body weight	Enquiry at recruitment and every 4 weeks up to 24 weeks	Patients report their body weight in kilograms at every point of survey.
Change in need for pancreatic enzyme supplements	Enquiry at recruitment and every 4 weeks up to 24 weeks	Patients report their need for pancreatic enzyme supplements at every point of survey

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Uusimaa, Finland