Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ

NCT03491254 | Unknown

• 1 other identifier: HE-201801
• Study Type: observational
• Target: 852
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice.

Conditions

Obstructive Jaundice

Outcome Measures

Primary Outcomes (1)

• Overall survival

  the time interval between baseline and the time of death due to any cause

  every 12 weeks until death, up to 48 weeks

Secondary Outcomes (8)

• overall survival rate

  48 weeks

• Median survival time (MST)

  48 weeks

• Karnofsky (KPS) score

  48 weeks

• Liver function 1

  12、24、36、48 weeks

• Liver function 2

  12、24、36、48 weeks

Study Arms (2)

Group A/exposure group

Huaier Granule \& biliary drainage

Group B/non-exposure group

biliary drainage.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant obstructive jaundice

You may qualify if:

• Male or female, aged between 18\~75 years;
• Naïve patients who were diagnosed as malignant obstructive jaundice that was caused by carcinoma of head of pancreas, cholangiocarcinoma, gallbladder carcinoma, or duodenal papilla carcinoma, or carcinoma metastasis in hilar lymph nodes based on clinical assessments and/or pathological examination;
• Total bilirubin \>80 umol/L;
• Patients who are not indicated for or refused to receive surgical resection;
• ECOG score ≤2 or KPS score ≥60;
• Expected survival time ≥12 weeks;
• Has signed and dated the informed consent in volunteer and are willing to comply with the data collection procedures by Investigator.

You may not qualify if:

• Female patients who are pregnant or breastfeeding;
• Patients who are receiving concomitant intravenous chemotherapy;
• Patients whose malignant obstructive jaundice was caused by liver cancer;
• Patients who have severe coagulation disorders and massive ascites;
• Patients with obstructive jaundice who have concomitant fever;
• Patients who are not applicable for or not willing to receive biliary drainage;
• Patients who are not appropriate to participate in the study at discretion of the Investigator.

Sponsors & Collaborators

• zhaoyu liu: lead

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

zhaoyu liu, Professor

CONTACT

+0086-18940251226; liuzhaoyu001@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 9, 2018
• Study Start: May 30, 2018
• Primary Completion: November 30, 2020
• Study Completion: May 31, 2021
• Last Updated: April 24, 2018

Record last verified: 2018-04