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Clinical Trials/JPRN-jRCTs042200064
JPRN-jRCTs042200064
Active, not recruiting
Phase 2

A prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of 7-mm-diamter covered metal stent for preoperative biliary drainage in resectable/borderline resectable pancreatic cancer

Ishiwatari Hirotoshi0 sites38 target enrollmentNovember 16, 2020
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Ishiwatari Hirotoshi
Enrollment
38
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 16, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ishiwatari Hirotoshi

Eligibility Criteria

Inclusion Criteria

  • •1\)A patient who is planned to undergo first endoscopic biliary stent placement for jaundice or cholangitis.
  • •2\)A patient with resectable or borderline resectable pancreatic cancer which is diagnosed by contrast CT.
  • •3\)A patient with distal biliary obstruction.
  • •4\)A patient \>\= 20 years old.
  • •5\)A patient with performance status of 0\-1\.
  • •6\)Will be followed for 6 months after treatment.
  • •7\)Written informed consent.

Exclusion Criteria

  • •1\)A patient with hilar biliary obstruction
  • •2\)A patient who underwent endoscopic biliary stent placement
  • •3\)A patient with duodenal obstruction/stenosis
  • •4\)A patient with acute pancreatitis
  • •5\)A patient who has a history of reconstruction method other than Billroth 1 anastomosis after gastrectomy.
  • •6\)A patient who cannot stop antiplatelet and coagulant drug.
  • •7\)A patient with mental disorder
  • •8\)A patient with severe organs failure, such as liver, bone marrow, and kidney.
  • •ANC \< 1000 mm3, Platelet count \< 50000 mm3,
  • •Hemoglobin \< 8\.0g/dL, Creatinine \>\= 2\.0mg/d

Outcomes

Primary Outcomes

Not specified

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