Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

NCT03069664 | Unknown

• 1 other identifier: Palliative pancreatic stenting
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer; Pancreatic Duct Stricture

Keywords

Pancreatic Cancer; Pancreatic Duct Stricture; Endoscopic treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in experienced strength of pain in visual analogue scale

  Enquiry at recruitment and every 4 weeks up to 24 weeks

• Change in body weight

  Enquiry at recruitment and every 4 weeks up to 24 weeks

• Change in need for pancreatic enzyme supplements

  Enquiry at recruitment and every 4 weeks up to 24 weeks

Study Arms (2)

Covered Self-expandable Metal Stent

ACTIVE COMPARATOR

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

Procedure: ERCP; Device: Covered Self-expandable Metal Stent

Control group

NO INTERVENTION

control group

Interventions

ERCP PROCEDURE

endoscopic retrograde cholangiopancreatography

Covered Self-expandable Metal Stent

Covered Self-expandable Metal Stent DEVICE

Pancreatic duct stent

Covered Self-expandable Metal Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients are not fit enough to undergo ERCP

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

Helsinki University Hospital

Helsinki, HUS, 00029, Finland

RECRUITING

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Leena Kylänpää, MD, PhD

  Helsinki UniversityHospital

  PRINCIPAL INVESTIGATOR

• Sini M Vehviläinen, MD

  Helsinki University Central Hospital

  STUDY CHAIR

• Hanna Seppänen, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Marianne Udd, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Outi Lindström, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

Central Study Contacts

Leena Kylänpää, MD, PhD

CONTACT

+358504272869; leena.kylanpaa@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: March 3, 2017
• Study Start: November 17, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)