Clinical trial NCT03069664: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Pancreatic Duct Stricture
Keywords: Pancreatic Cancer
Pancreatic Duct Stricture
Endoscopic treatment
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in experienced quality of life
timeFrame: Enquiry at recruitment and every 4 weeks up to 24 weeks
Secondary outcomes:
measure: Change in experienced strength of pain in visual analogue scale
timeFrame: Enquiry at recruitment and every 4 weeks up to 24 weeks
measure: Change in body weight
timeFrame: Enquiry at recruitment and every 4 weeks up to 24 weeks
measure: Change in need for pancreatic enzyme supplements
timeFrame: Enquiry at recruitment and every 4 weeks up to 24 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: HUS
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki UniversityHospital
name: Leena Kylänpää, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Sini M Vehviläinen, MD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Hanna Seppänen, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Marianne Udd, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Outi Lindström, MD, PhD
role: STUDY_CHAIR
References: