A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy

A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy - A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041035

Enrollment

Registered

2020-07-08

Start date

2020-07-09

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

pancreatic cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years or older at the time of obtaining consent 2)Patients diagnosed with pancreatic cancer by histological diagnosis or imaging tests (CT or MRI) 3) Patients with middle and lower bile duct stenosis 4) Patients who have been judged by a doctor to be able to place a self-expanding metal stent (SEMS) 5) Patients scheduled to undergo preoperative chemotherapy (NAC) 6) Patients scheduled for surgery 7) Patients who can obtain their consent for participation in this study

Exclusion criteria

Exclusion criteria: 1) Patients with Performance status 3 or 4 2) Women who are pregnant or may be pregnant 3) Patients with severe complications that affect resection or chemotherapy such as heart disease, liver disease, renal disorder 4) Patients with a distance from the hilum of the stenosis to the upper end of the stenosis of 2 cm 5) Patients with Gastic outlet obstruction due to anal stenosis 6) Cases where endoscopic approach is difficult 7) Reconstruction other than Billroth 1 method after gastrectomy 8) Cases with distant metastasis 9) Patients who are judged to be inappropriate as a subject by the doctor's judgment

Design outcomes

Primary

Measure	Time frame
Incidence of recurrent biliary obstruction (RBO) that develops before surgery	—

Secondary

Measure	Time frame
(1)Time to recurrent biliary obstruction (TRBO) (2) Incidence of cholecystitis (3) Adverse events other than RBO (4) Impact on surgery	—

Countries

Japan

Contacts

Public ContactIkuhiro Kobori

Dokkyo Medical University Saitama Medical Center Gastroenterology

viva.s.a.410@gmail.com048-965-1111

Outcome results