Preoperative SEMS trial
Phase 3
Recruiting
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCTs032180288
- Lead Sponsor
- Isayama Hiroyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1)20 years old. regardless of sex.
2)Written informed consent
3)resectable or borderline resectable pancreatic cancer
4)adenocarcinoma or adenosquamous carcinoma or obvious pancreatic cancer
5)with distal biliary obstruction
6)need for Biliary Drainage
7)less than 2 weeks from Biliary Drainage
Exclusion Criteria
1)under 2cm from hilar bile duct to stenosis
2)with Gastric outlet obstruction
3)with Serious complications
4)endoscopic approach is difficult
5)except Billroth I reconstruction
6)Benign stenosis
7)Hilar bile duct stenosis
8)more than 2 weeks from Biliary Drainage
9)less than 2 weeks until operation
10)with metastasis
11)Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of accident from the time of biliary stent placement to the surgery.
- Secondary Outcome Measures
Name Time Method Preoperative recurrent biliary obstruction (RBO) rate,<br>Time to recurrent biliary obstruction, re-interevention rate, surgical execution rate, incidence of accident in the perioperative period, Clavian-Dindo( postoperative complication criteria of JCOG), ISGPF(International study group of postoperative pancreaticfistula), cost comparison