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Biliary partially-covered Wallflex for bridge to surgery in patients with pancreatic cancer receiving neo-adjuvant chemotherapy

Biliary partially-covered Wallflex for bridge to surgery in patients with pancreatic cancer receiving neo-adjuvant chemotherapy - BTS-NAC study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000011855
Enrollment
30
Registered
2013-09-25
Start date
2013-09-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

resectable or borderline resectable pancreatic cancer undergoing neo-adjuvant chemotherapy

Interventions

None listed

Sponsors

The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Biliary drainage using a paritially-covered SEMS 2) Scheduled for neoadjuvant chemotherapy or chemoradiotherapy 3) Distal malignant biliary obstruction due to pancreatic cancer 4) Age 20 or older 5) Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1) Location of distal biliary obstruction such that it would not allow the proximal end of a stent to be positioned at least 2 cm from the hilum 2) Patients with duodenal obstruction anal to the ampulla 3) Tumor involvement to the orifice of cystic duct 4) Previous biliary drainage by ENBD or EBD more than 2 weeks 5) Patients with severely impaired organ function 6) Patients for whom endoscopic biliary drainage is difficult 7) Patients with distant metastasis 8) Hilar biliary obstruction 9) Without pathological diagnosis 10) Patients considered ineligible for this study

Design outcomes

Primary

MeasureTime frame
Incidence of recurrent biliary obstruction prior to surgery

Secondary

MeasureTime frame
Time to recurrent biliary obstruction (TRBO), adverse events, overall survival, stent removal at the time of surgery.

Countries

Japan

Contacts

Public ContactKei Saito

The University of Tokyo Gastroenterology

saitoke-int@h.u-tokyo.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026