Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03578055
Other study ID # BULQ-LC trial
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 24, 2018
Est. completion date December 31, 2019

Study information

Verified date July 2018
Source Ewha Womans University Mokdong Hospital
Contact Huisong Lee, M.D., Ph.D.
Phone +82-2-2650-5694
Email huisong.lee@ewha.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy

Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase)

Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score


Description:

Because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. BDD and UDCA drugs are known to be effective in preserving liver function. The use of BDD and UDCA drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. The aim of this study is to analyze the effects of BDD and UDCA medication on postoperative changes in hepatic enzyme levels and quality of life in patients LFT elevated cholecystitis.


Recruitment information / eligibility

Status Recruiting
Enrollment 172
Est. completion date December 31, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients scheduled for surgery due to chronic cholecystitis and acute cholecystitis

Exclusion Criteria:

- Failure to obtain consent

- Under 19 years

- If you have intellectual ability to understand this study

- When performing cholecystectomy with other operations

- Total bilirubin levels> 2 mg / dl

- If you are enrolled in another clinical trial

Study Design


Intervention

Drug:
BDD with UDCA
Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
Placebo
Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery

Locations

Country Name City State
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Aspartate Aminotransferase Serum aspartate aminotransferase level (U/ml) (continuous variable) Postoperative 30 days
Primary Serum Alanine Aminotransferase Serum Alanine Aminotransferase level (U/ml) (continuous variable) Postoperative 30 days
Secondary GIQLI (Gastrointestinal Quality of Life Index) Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180) Postoperative 30 days
See also
  Status Clinical Trial Phase
Completed NCT03767881 - AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE N/A
Recruiting NCT05975385 - Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy N/A
Completed NCT03470220 - The Role of Ultrasound in Cholecystitis
Recruiting NCT02972944 - Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients N/A
Recruiting NCT05702775 - Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis N/A
Recruiting NCT04542512 - Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic.
Recruiting NCT04103762 - Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis N/A
Completed NCT03014817 - Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial N/A
Active, not recruiting NCT04612413 - A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients Phase 2
Withdrawn NCT04167072 - Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy N/A
Completed NCT04874103 - Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis
Completed NCT05041686 - Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy N/A
Not yet recruiting NCT05339282 - Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease N/A
Recruiting NCT06330688 - Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Completed NCT02619149 - Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis Phase 3
Not yet recruiting NCT04661371 - Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis N/A
Completed NCT03050242 - Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®) N/A
Completed NCT06178848 - EEG Parameters Between Remimazolam- and Propofol-based Anesthesia N/A
Completed NCT02394327 - Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy N/A
Completed NCT05179629 - M-Tapa Block for Laparoscopic Cholesistectomy N/A