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Clinical Trials/NL-OMON38754
NL-OMON38754
Withdrawn
Not Applicable

Endobiliary radiofrequency ablation as treatment for occluded extra-hepatic biliary metal stents: a prospective multicenter feasibility study. - Endobiliary RFA for occluded extra-hepatic biliary SEMS

Academisch Medisch Centrum0 sites20 target enrollmentTBD
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Conditionspancreascarcinoommalignant extra-hepatic biliary obstruction1001981510019818

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
pancreascarcinoom
Sponsor
Academisch Medisch Centrum
Enrollment
20
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients with unresectable malignant common bile duct obstruction caused by pancreatic head carcinoma or distal cholangiocarcinoma who have been treated previously with a biliary uncovered SEMS
  • •Recurrent biliary obstruction caused by SEMS occlusion due to tissue ingrowth, requiring treatment
  • •A clinical diagnosis of obstructive jaundice in combination with a bilirubin level of \>40 µmol/L and

Exclusion Criteria

  • •Patients with a (malignant) biliary obstruction due to other causes than pancreatic head cancer or cholangiocarcinoma
  • •Evidence of new additional more proximally located biliary strictures
  • •Clinical suspicion of cholangitis, defined as biliary obstruction in combination with fever (temperature \>\= 38,5°C)
  • •Presence of a plastic stent in the common bile duct.
  • •Patients who are unable to undergo ERCP due to their medical condition
  • •Patients suffering form concurrent gastric outlet obstruction
  • •Patients with a cardiac pacemaker
  • •Patients with a WHO performance score of 4

Outcomes

Primary Outcomes

Not specified

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