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

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03527875
• Collaborator: (none)
• Enrollment: 564
• Arms: 4
• Anticipated Duration (Months): 47

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Jaundice, Obstructive; Klatskin Tumor	Procedure: PTBD group; Procedure: ENBD group; Procedure: EBS group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 564 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice of Extrahepatic Bile Duct: A Multi-center, Prospective, Open-labeled, Real World Study Based on Electronic Data Capture System
• Anticipated Study Start Date: Aug 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTBD group Percutaneous Transhepatic Biliary Drainage	Procedure: PTBD group; Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Experimental: ENBD group Endoscopic Nasobiliary Biliary Drainage	Procedure: ENBD group; Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Experimental: EBS group Endoscopic Biliary Stenting	Procedure: EBS group; Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
No Intervention: Without PBD group receive surgery without PBD

Outcome Measures

Primary Outcome Measures

1. Complication rate after drainage [From PBD to completion of radical surgery, an average of 1 month]

   Complication rate between PBD (preoperative biliary drainage) and radical surgery

2. Complication rate after radical surgery [1 month post operatively]

   Complication rate after radical surgery

3. Success rate of PBD [Day 1]

   Success rate of different methods of PBD

Secondary Outcome Measures

1. operative time [Day 1]

   duration of radical surgery

2. Hepatoduodenal edema [at time of radical surgery]

   Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)

3. Perioperative mortality [from PBD to 4 weeks after surgery, an average of 2 month]

   Mortality between PBD and 4 weeks after surgery

4. implantation metastasis [Day 1]

   Rate of implantation metastasis

5. Rate of change in Total bilirubin [2 weeks after PBD]

   Recovery efficiency of liver function

6. Rate of change in alanine aminotransferase [2 weeks after PBD]

   Recovery efficiency of liver function

7. Rate of change in aspartate aminotransferase [2 weeks after PBD]

   Recovery efficiency of liver function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who meet the following four criteria are included into the study:

1. Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;

2. Serum total bilirubin is higher than 51 umol/l;

3. Age is older than 18 and younger than 80 years old;

4. Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.

Exclusion Criteria:

• If any of the following items are met, the subject cannot enter the study.

1. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;

2. Malignant obstructive jaundice caused by metastatic tumors;

3. Pregnancy or lactation women.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03527875
• Other Study ID Numbers: 2018ZSLC24
• First Posted: May 17, 2018
• Last Update Posted: Jun 6, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Klatskin Tumor; Jaundice; Jaundice, Obstructive

Study Results

No Results Posted as of Jun 6, 2018