UDCA for Symptomatic Gallstone Disease

Learn more about:
Related Clinical Trial
Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis Prognostic Indicators as Provided by the EPIC ClearView WSES International Register of Emergency Surgery Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections. Prospective Validation of “Cholecystectomy First” Strategy for Gallstone Migration ONSD According to the Position During Laparoscopy Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy Drainage or Not for Laparoscopic Cholecystetomy UDCA for Symptomatic Gallstone Disease Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Transvaginal Cholecystectomy Using Endoscopic Assistance Doripenem in the Treatment of Complicated Intra-Abdominal Infections Doripenem in the Treatment of Complicated Intra-Abdominal Infections The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy Evaluation of PC 6 “Neiguan” With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy. Role of the Right Portal Pedicle and Rouviere’s Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. NOTES-Assisted Laparoscopic Cholecystectomy Surgery EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy Fluorescence Cholangiography During Cholecystectomy – a RCT Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA FALCON: a Multicenter Randomized Controlled Trial Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy 3D Versus 4K Laparoscopic Cholecystectomy Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy Effect of Modified Stylet Angulation on the Intubation With GlideScope® Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor BDD With UDCA Therapy After Laparoscopic Cholecystectomy Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy Postoperative Pain Results According to Pressure to Form Pneumoperitoneum Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®) Prediction of Postoperative Pain by Injection Pain of Propofol Transient ECG Changes in Patients With Acute Biliary Disease Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy Establishing Visualization Grading Scale on LESS Cholecystectomy Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy A Clinical Study of Chinese Domestic Surgical Robot Laparoscopic Cholecystectomy: Study of Left Side of Laparoscopic Cholecystectomy Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Effects of Drainage in Laparoscopic Cholecystectomy Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain Early Versus Delayed Cholecystectomy If Chronic Gallbladder Diseases Increase the Incidence of PEC Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy — Use in Acute Cholecystitis Sub-Study The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy Enhanced Recovery in Laparoscopic Cholecystectomy Empirical Antibiotics in Acute Inflammatory Gallbladder Disease Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement. Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms Bile Aspiration vs Drain in Acute Cholecystitis Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis Fluorescent Cholangiography During Acute Cholecystitis Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder? Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy Scoring System in Acute Calculous Cholecystitis Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? Fast Track Pathway to Accelerated Cholecystectomy Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA) Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study. Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis The Role of Ultrasound in Cholecystitis AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis The Real World of Acute Cholecystitis Functional MRC With Eovist for Acute Cholecystitis FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

Brief Title

UDCA for Symptomatic Gallstone Disease

Official Title

Studie Naar De Effectiviteit Van Ursodeoxycholzuur Ter Preventie Van Galsteen-Gerelateerde Klachten Bij patiënten in Afwachting Van Een Cholecystectomie

Brief Summary

      We conduct a randomized, double-blind, placebo-controlled trial on effects of UDCA on biliary
      pain and complications in highly symptomatic gallstone patients scheduled for
      cholecystectomy. We also evaluate potential beneficial effects of impaired gallbladder
      motility
    

Detailed Description

      Gallstone disease is very common with an estimated prevalence of 10-15% in the adult Western
      population. Approximately 90% of gallstone carriers are asymptomatic. The annual risk of
      biliary colic in asymptomatic gallstone carriers has been suggested to be approximately 1%.
      Also, asymptomatic gallstone carriers are at risk for acute pancreatitis, choledocholithiasis
      and acute cholecystitis. Although accurate prospective data are lacking, annual incidences of
      these potentially lethal complications are estimated to be approximately 0.2%, 0.2% and 0.3%,
      respectively.

      One can easily imagine that migration of gallbladder stones into the common bile duct may
      lead to biliary pain. How gallbladder stones remaining in the gallbladder lead to biliary
      symptoms is not entirely clear. Strong gallbladder contraction, with temporary impaction of
      the stone in the orifice of the cystic duct might cause biliary pain. Although impaired
      gallbladder motility could therefore theoretically protect against colics, symptomatic
      gallbladder stone patients often have complaints despite coexistent impaired gallbladder
      emptying.

      Ursodeoxycholic acid (UDCA) has been claimed to reduce the risk of biliary pain, regardless
      of gallstone dissolution. In a large study by Tomida et al., risks of biliary pain or
      gallstone complications (acute cholecystitis) were reduced in both symptomatic and
      asymptomatic gallstone carriers, although gallstones were generally not dissolved. Also,
      biliary pancreatitis might be prevented by long-term UDCA treatment. Increased fasting and
      residual postprandial gallbladder volumes during UDCA treatment, less cholesterol crystals or
      decreased mucin contents in bile could be the underlying mechanisms for these beneficial
      effects. However, prospective studies on effects of UDCA on symptoms or complications in
      highly symptomatic patients are lacking.

      In the Netherlands symptomatic gallstone patients are admitted to a waiting list for elective
      cholecystectomy by general surgeons. The waiting period may last several months because of
      logistic reasons. During this waiting period gallstone patients are at risk for biliary pain
      and complications. Therefore, we conducted a randomized, double-blind, placebo-controlled
      trial on effects of UDCA on biliary pain and complications in highly symptomatic gallstone
      patients scheduled for cholecystectomy. We also evaluated potential beneficial effects of
      impaired gallbladder motility
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

incidence severe right upper quadrant or midline epigastric pain (> 30 min)and colic-free intervals

Secondary Outcome

 nr gallstone complications (acute cholecystitis, choledocholithiasis or acute pancreatitis) and non-severe right upper quadrant or midline epigastric pain and nr aalgesics taken

Condition

Cholecystolithiasis

Intervention

ursodeoxycholic acid


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

180

Start Date

November 2001

Completion Date

November 2004


Eligibility Criteria

        Inclusion Criteria:

          -  Patients between 18 and 75 years of age study are upon admission to the waiting list
             for elective cholecystectomy for symptomatic cholecystolithiasis defined as:

               -  presence of gallbladder stones or sludge, without bile duct stones or bile duct
                  dilatation at ultrasonography;\

               -  at least one episode of severe right upper quadrant or midline epigastric pain of
                  at least 30 min. duration, with radiation and/or movement urge, or at least three
                  episodes of severe right upper quadrant or midline epigastric pain of at least 30
                  min. duration without such radiation or movement urge, in the previous 12 months

        Exclusion Criteria:

          -  Contra-indication for general anaesthesia or surgery

          -  Current or previous acute cholecystitis, obstructive jaundice or pancreatitis

          -  Previous papillotomy, because of preferential flow of UDCA-enriched bile to the
             intestine rather than to the gallbladder

          -  Pregnancy or lactation

          -  Current or previous use of UDCA

          -  Participation in another study

          -  Inability to speak Dutch or English or mental disability
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Niels G Venneman, MD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT00161083

Organization ID

MLDS WS 00-08

Secondary IDs

MLDS WS 00-08


Study Sponsor

UMC Utrecht

Collaborators

 Dr. Falk Pharma GmbH

Study Sponsor

Niels G Venneman, MD, Principal Investigator, UMC Utrecht


Verification Date

September 2005