D-ARMS vs conventional CMS for distal MBO in pancreatic cancer

Phase 3

Recruiting

• Conditions: Pancreatic cancer; Pancreatic cancer, malignant distal biliary obstruction

• Registration Number: JPRN-jRCT1032230171
• Lead Sponsor: Sasahira Naoki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1)Unresectable pancreatic cancer
2)Prior history of one endoscopic stenting with covered metal stent
3)Dysfunction of previous covered metal stent
4)Age >= 18 years
5)Performance status of 0-2
6)Expected survival time over 3 months
7)Sufficient organ function
1.Neutrophil count >= 1,000 /microL
2.Hemoglobin level >= 7.0 g/dL
3.Platelet count >= 50,000 /microL
4.Total bilirubin level =< 10 mg/dL
5.Aspartate aminotransferase level =< 300 U/L
6.Alanine aminotransferase level =< 300 U/L
7.Creatinine level =< 2.0 mg/dL
8)Patients who provided a written consent

Exclusion Criteria

1)Concomitant hilar biliary obstruction
2)Patients who require more than one biliary stent
3)Unable to remove the previous covered metal stent
4)Surgically altered anatomy other than Billroth 1 reconstruction
5)Indwelling Pholangitis
7)Cholecystitis requiring gallbladder drainage
8)Liver abscess requiring abscess drainage
9)Liver failure
10)Indwelling gastroduodenal stent covering the duodenal papilla
11)Uncontrolled gastrointestinal obstruction
12)Massive ascites requiring palliative paracentesis
13)Patients who would become lost to follow up right after metal stent placement
14)Patients who are pregnant or may become pregnant
15)Patients who are considered inappropriate by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Recurrent Biliary Obstruction

Secondary Outcome Measures

Name	Time	Method
1)Technical success rate<br>2)Clinical success rate<br>3)Early complication rate<br>4)Recurrent biliary obstruction rate<br>5)Adverse event rate<br>6)Success rate of stent removal<br>7)Overall survival after covered metal stent placement