UnknownNot Applicable

Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice

564 participantsStarted 2018-08

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;
✓. Serum total bilirubin is higher than 51 umol/l;
✓. Age is older than 18 and younger than 80 years old;
✓. Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.

Exclusion criteria

✕. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;
✕. Malignant obstructive jaundice caused by metastatic tumors;
✕. Pregnancy or lactation women.

What they're measuring

Complication rate after drainage

Timeframe: From PBD to completion of radical surgery, an average of 1 month

Complication rate after radical surgery

Timeframe: 1 month post operatively

Success rate of PBD

Timeframe: Day 1

Trial details

NCT IDNCT03527875

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

Houbao Liu, PHD

13818971698 houbaoliu@aliyun.com

View on ClinicalTrials.gov More Jaundice, Obstructive trials