Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

August 15, 2022 updated by: Leena Kylanpaa, Helsinki University Central Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • HUS
      • Helsinki, HUS, Finland, 00029
        • Recruiting
        • Helsinki University Hospital
        • Contact:
        • Sub-Investigator:
          • Sini Vehviläinen, MD
        • Sub-Investigator:
          • Hanna Seppänen, MD, PhD
        • Sub-Investigator:
          • Outi Lindström, MD, PhD
        • Sub-Investigator:
          • Marianne Udd, MD, PhD
        • Sub-Investigator:
          • Johanna Louhimo, MD, PhD
        • Sub-Investigator:
          • Arto Kokkola, MD, PhD
        • Principal Investigator:
          • Leena Kylänpää, MD, PhD
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Covered Self-expandable Metal Stent
ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent
Procedure: ERCP
endoscopic retrograde cholangiopancreatography
Device: Covered Self-expandable Metal Stent
Pancreatic duct stent
NO_INTERVENTION: Control group
control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in experienced quality of life
Time Frame: 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.
Enquiry at recruitment and every 4 weeks up to 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Leena Kylänpää, MD, PhD, Helsinki UniversityHospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 17, 2017

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

February 19, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Palliative pancreatic stenting

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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