Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03069664
• Other study ID #: Palliative pancreatic stenting
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Helsinki University Central Hospital
• Contact: Leena Kylänpää, MD, PhD
• Phone: +358504272869
• Email: leena.kylanpaa[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Pancreatic Cancer
• Pancreatic Duct Stricture
• Pancreatic Neoplasms

Intervention

Procedure:
• ERCP
endoscopic retrograde cholangiopancreatography

Device:
• Covered Self-expandable Metal Stent
Pancreatic duct stent

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	HUS
Finland	Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in experienced quality of life	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.	Enquiry at recruitment and every 4 weeks up to 24 weeks
Secondary	Change in experienced strength of pain in visual analogue scale	Patients evaluate the strength of pain in visual analogue scale	Enquiry at recruitment and every 4 weeks up to 24 weeks
Secondary	Change in body weight	Patients report their body weight in kilograms at every point of survey.	Enquiry at recruitment and every 4 weeks up to 24 weeks
Secondary	Change in need for pancreatic enzyme supplements	Patients report their need for pancreatic enzyme supplements at every point of survey	Enquiry at recruitment and every 4 weeks up to 24 weeks