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CompletedNCT00501176Updated Jun 29, 2022

Preoperative Stent Study

An interventional study of Plastic and metalic stent inserion in Pancreas Cancer, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-06-29.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

Randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to Whipple operation.

Read the detailed description

Patients suffering from a locally invasive tumour process in the Periampullary area usually seek medical attention because of jaundice. Not only do patients suffering from jaundice show significant symptoms of exhaustion and purities, but they are also at higher risk for developing post-operative complications. Experimentally, the liver exhibits a reduced capacity for tolerating ischemia in the presence of jaundice. Several different etiologic factors suggest cause complication such as presence of toxic substances as bilirubin and bile salts, impaired nutritional status, effects of endotoxins, bacterial translocation, modulation of the inflammatory cascade with cytokine release, reduction of cellular immunity and nutritional. These complications primarily consist of septic complications (cholangitis, abscesses, and leakage), haemorrhage, impaired wound healing and renal disorders. Summarily, these issues have motivated pre-operative bile flow drainage by way of stent. Traditionally, pre-operative bile flow drainage has been achieved by insertion of a EP because these are considered easy to remove and cause less tissue reaction in the bile ducts. However, multiple studies have found the disadvantage with the EP is that it provides poorer bile drainage than the SEMS.

In palliative situations, metal stents have been associated with fewer side-effects in the form of fever relapse of jaundice, etc. These effects are likely due to better bile flow through the stent. It remains unclear if metal stents can provide similar advantages in the curative situation.

02

Conditions studied

  • Pancreas Cancer

Keywords

  • Pancreas
  • cancer
  • SEMS
  • Plastic
  • stent
  • Whipple
  • Jaundicie
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 92 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The primary inclusion criteria are all patients with operable Periampullary cancer and jaundice who have not previously undergone bile flow drainage.

Exclusion criteria

Exclusion Criteria:

  • Define as failed ERCP, patients who have previously undergone bile flow drainage or radical surgery is not possible.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
92 participants (actual)

Study arms

  • Active comparator
    plastic stent

    Stent insertion

    Procedure: Plastic and metalic stent inserion

  • Active comparator
    metalic stent

    Stent inserttion

    Procedure: Plastic and metalic stent inserion

Interventions

  • ProcedurePlastic and metalic stent inserion

    Patient randomizes to metal or plastic insertion prior to Whipple procedure

    Also known as: Two types of Stent prior to Whipple procedure

06

What researchers measure

Primary outcomes

  1. Intra-operative measurement of the Culture from the bile.

    Time frame: Intraoperativt

Secondary outcomes

  1. Intraoperative measurements of inflammatory reaction in the liver, hepatoduodenal ligament and around the bile ducts with biopsies. Stent dysfunction and cholangitis after ERCP and pre-operative bile flow relief. Postoperative analysis.

    Time frame: Perioperative

07

Study locations

1 site
  • Karolinksa University Hospital
    Stockholm, 14186, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00501176
Lead sponsor
Karolinska Institutet
Responsible party
Sponsor
First posted
Jul 13, 2007
Start date
Dec 2006
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Jun 29, 2022

Study contacts

Lars Enochsson, MD, PhD
principal investigator · Karolinksa Institutet
Urban Arnelo, M.D.
study director · Karolinska Institutet
Lars Lundell, Professor
study chair · Karolinska Institutet

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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