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Trial record 71 of 2867 for:    Pancreatic Cancer AND pancreas

Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03069664
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Leena Kylanpaa, 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Duct Stricture Procedure: ERCP Device: Covered Self-expandable Metal Stent Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069664


Contacts
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Contact: Leena Kylänpää, MD, PhD +358504272869 leena.kylanpaa@hus.fi

Locations
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Finland
Helsinki University Hospital Not yet recruiting
Helsinki, HUS, Finland, 00029
Contact: Leena Kylänpää, MD, PhD    +358504272869    leena.kylanpaa@hus.fi   
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         
Helsinki University Hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Leena Kylänpää       leena.kylanpaa@hus.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Leena Kylänpää, MD, PhD Helsinki University Central Hospital
Study Chair: Sini Vehviläinen, MD Päijänne Tavastia 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: Arto Kokkola, MD, PhD Helsinki University Central Hospital

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Responsible Party: Leena Kylanpaa, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03069664     History of Changes
Other Study ID Numbers: Palliative pancreatic stenting
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leena Kylanpaa, Helsinki University Central Hospital:
Pancreatic Cancer
Pancreatic Duct Stricture
Endoscopic treatment
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Constriction, Pathologic
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical