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Clinical Trials/JPRN-jRCTs052210032
JPRN-jRCTs052210032
Suspended
Phase 3

A multicenter, randomized, controlled trial to reveal the efficacy of low axial force designed Dumbbell head shaped SEMS (self-expandable metallic stent) for malignant biliary obstruction caused by unresectable pancreatic cancer (fully covered vs. uncovered)(confirmatory trial) - LPAC Study

Takenaka Mamoru0 sites300 target enrollmentJune 2, 2021
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Conditionsmalignant biliary obstruction caused by unresectable pancreatic cancermalignant biliary obstruction, unresectable pancreatic cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
malignant biliary obstruction caused by unresectable pancreatic cancer
Sponsor
Takenaka Mamoru
Enrollment
300
Status
Suspended
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Takenaka Mamoru

Eligibility Criteria

Inclusion Criteria

  • •(1\)Unresectable pancreatic cancer (UR\-LA,UR\-M) causing distal biliary obstruction
  • •(2\)Pathologically confirmed diagnosis or patients with suspected pancreatic cancer who are scheduled to undergo a pathological examination(It does not matter whether it is by cytology or histology)
  • •(3\)Patients aged 20 and over who have given sufficient explanation about the content of the study and have proved informed consent created by the patient's will based on the understanding of the content. (In principle, cancer notification shall be given.)

Exclusion Criteria

  • •(1\)Cases with Performance status of 4
  • •(2\)Cases with serious complications in other organs.such as ASA classification 3 or higher (Subject who is dialysis also excluded)
  • •(3\)Cases with hilar biliary obstruction
  • •(4\)Cases with bordeline resectable pancreatic cancer (BR), hilar biliary obstruction associated with lymphadenopathy
  • •(5\)Cases where informed consent cannot be obtained
  • •(6\)Cases with Uncontrollable cholangitis
  • •(7\)Cases with an expected prognosis of less than 3 months
  • •(8\)Cases where the condition worsens after the first biliary drainage
  • •(9\)Cases judged by the investigator (in\-charge doctor) to be inappropriate as a subject

Outcomes

Primary Outcomes

Not specified

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