A prospective randomized Trial: Effect on Rowachol in patient with obstructive jaundice

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000265

Enrollment

Registered

2011-11-11

Start date

2011-04-04

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients that are indicated for biliary drainage due to pancreato-biliary malignancy related obstructive jaundice will be randomized into Rowachol group and placebo group. The groups will be gi

pinene 17 mg, camphene 5 mg, cineol 2 mg, menthone 6 mg, menthol 32 mg, borneol 5 mg Placebo contains only diluting agents and does not contain active complex. Rowachol and placebo will be produced i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who are diagnosed with pancreato-biliary malignancy, and are between the age of 20 and 85 (20= <85) - Confirmed obstructive jaundice - Patients without history of other chemotherapy or radiotherapy - Patients without cardiovascular, pulmonologic, or urinary disease that affects daily life activities - Karnofsky performance scale of 50 or more - Patients with written informed consent - Patients without history of underlying nutritional disorder or liver disease such as acute hepatitis and liver cirrhosis - Patients without history of uncontrolled cardiovascular, pulmonary, or hematologic disorder

Exclusion criteria

Exclusion criteria: - Patient that are under 20 years of age or over 85 years - Patients with nausea and vomiting due to severe gastric outlet obstruction - Patient with history of chemotherapy or radiotherapy - Patient with active or intractable inflammation other than cholangitis - Patient who are under medications that affects liver metabolism - Patient who do not consent to the study - Patient who are incapable of understanding or communicating - Karnofsky performance scale of less than 50

Design outcomes

Primary

Measure	Time frame
mean drainage amount during 2 weeks and LFT for PTBD group, and LFT for ERBD group	—

Secondary

Measure	Time frame
liver biopsy;operation-raleted factors suc as blood loss, operative time, etc.;surgical complication such as anastomosis failure, bile leak, cholangitis, pancreatitis, postoperative bleeding, delayed gastric empying, intestinal perforation, pneumonia;quality of life with EORTC QLQ c-30	—

Countries

Korea, Republic of

Contacts

Public ContactIn Woong Han

Seoul National University Hospital

Outcome results