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Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Pancreatic Duct Stricture

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

ERCP

Covered Self-expandable Metal Stent

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Pancreatic Duct Stricture, Endoscopic treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University HospitalRecruiting
Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Covered Self-expandable Metal Stent

Control group

Arm Description

ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent

control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in experienced strength of pain in visual analogue scale

Patients evaluate the strength of pain in visual analogue scale

Change in body weight

Patients report their body weight in kilograms at every point of survey.

Change in need for pancreatic enzyme supplements

Patients report their need for pancreatic enzyme supplements at every point of survey

Full Information

NCT ID

NCT03069664

First Posted

February 19, 2017

Last Updated

August 15, 2022

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03069664

Brief Title

Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Official Title

Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 17, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Pancreatic Duct Stricture

Keywords

Pancreatic Cancer, Pancreatic Duct Stricture, Endoscopic treatment

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Covered Self-expandable Metal Stent

Arm Type

Active Comparator

Arm Description

ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent

Arm Title

Control group

Arm Type

No Intervention

Arm Description

control group

Intervention Type

Procedure

Intervention Name(s)

ERCP

Intervention Description

endoscopic retrograde cholangiopancreatography

Intervention Type

Device

Intervention Name(s)

Covered Self-expandable Metal Stent

Intervention Description

Pancreatic duct stent

Primary Outcome Measure Information:

Title

Change in experienced quality of life

Description

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.

Time Frame

Enquiry at recruitment and every 4 weeks up to 24 weeks

Secondary Outcome Measure Information:

Title

Change in experienced strength of pain in visual analogue scale

Description

Patients evaluate the strength of pain in visual analogue scale

Time Frame

Enquiry at recruitment and every 4 weeks up to 24 weeks

Title

Change in body weight

Description

Patients report their body weight in kilograms at every point of survey.

Time Frame

Enquiry at recruitment and every 4 weeks up to 24 weeks

Title

Change in need for pancreatic enzyme supplements

Description

Patients report their need for pancreatic enzyme supplements at every point of survey

Time Frame

Enquiry at recruitment and every 4 weeks up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leena Kylänpää, MD, PhD

Phone

+358504272869

leena.kylanpaa@hus.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leena Kylänpää, MD, PhD

Organizational Affiliation

Helsinki UniversityHospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sini M Vehviläinen, MD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hanna Seppänen, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marianne Udd, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Outi Lindström, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Helsinki University Hospital

City

Helsinki

State/Province

HUS

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leena Kylänpää, MD, PhD

Phone

+358504272869

leena.kylanpaa@hus.fi

First Name & Middle Initial & Last Name & Degree

Sini Vehviläinen, MD

First Name & Middle Initial & Last Name & Degree

Hanna Seppänen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Outi Lindström, MD, PhD

First Name & Middle Initial & Last Name & Degree

Marianne Udd, MD, PhD

First Name & Middle Initial & Last Name & Degree

Johanna Louhimo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Arto Kokkola, MD, PhD

First Name & Middle Initial & Last Name & Degree

Leena Kylänpää, MD, PhD

Facility Name

Helsinki University Hospital

City

Helsinki

State/Province

Uusimaa

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leena Kylänpää

leena.kylanpaa@hus.fi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

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