Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

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

Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

Official Title

An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration

Brief Summary

      The purpose of this study is to evaluate if cholecystectomy first (studied group) versus
      sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of
      hospital stay, morbidity/mortality and costs in the management of patients with a suspicion
      of gallstone migration.
    

Detailed Description

      Emergency cholecystectomy is nowadays an accepted surgical procedure routinely performed
      worldwide. The main indications include acute cholecystitis, cholangitis and gallstone
      migration. Abnormal liver function tests upon admission and suspicion for accompanying common
      bile duct (CBD) stone can delay the surgical management due to the need for further
      investigations and/or therapeutic maneuvers. These procedures include magnetic resonance
      cholangio-pancreatography (MRCP), endoscopic ultrasound (EUS) and endoscopic retrograde
      cholangio-pancreatography (ERCP).

      While useful to detect or exclude potential CBD stones, these procedures include inherent
      risks, delay the surgical treatment, extend hospital stay and as a result, increase the
      overall medical costs. They can also potentially increase the morbidity and/or mortality by
      delaying emergency cholecystectomy (due to the presence of more local inflammation and
      adherence). Finally, more and more centers perform systematic intra-operative cholangiogram
      during cholecystectomies (laparoscopic or open), which allow an accurate assessment of the
      CBD and potentially lead to its subsequent exploration (endoscopic or surgical).

      In this study, the investigators will assess the following hypotheses:

        -  Patients with a SUSPICION of gallstone migration (with or without associated
           cholecystitis) should undergo emergency cholecystectomy with intra-operative
           cholangiogram (IOC) first

        -  "Cholecystectomy first" strategy will decrease both the length of hospital stay and the
           morbidity/mortality by decreasing the number of unnecessary EUS, MRCP and ERCP and
           therefore decreasing the overall number of their complications, as well as decreasing
           the complications related to delayed cholecystectomy (increased adherences due to
           inflammation, especially in case of associated cholecystitis, which increase the risk of
           bleeding, CBD lesion, duodenal lesion, gastric lesion, colon lesion, gallbladder
           perforation and intra-abdominal gallstones spillage with potential
    


Study Type

Interventional


Primary Outcome

Hospital stay [days]

Secondary Outcome

 Morbidity

Condition

Cholelithiasis

Intervention

Emergency cholecystectomy first

Study Arms / Comparison Groups

 Cholecystectomy first
Description:  Patients enrolled in this arm will undergo emergency cholecystectomy first without any common bile duct imaging

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

Procedure

Estimated Enrollment

100

Start Date

June 2011

Completion Date

August 2013

Primary Completion Date

February 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have a clinical diagnosis of gallstone migration, defined as right upper
             quadrant or epigastric abdominal pain and abnormal liver function tests (increase of
             at least two common hepatic parameters [AST, ALT, alkaline phosphatase, gGT and/or
             bilirubin], with one of them being either AST or ALT with a value at least two times
             higher than the norm) with a reasonable exclusion of other common differential
             diagnoses

          -  Patients will be included regardless the presence of an associated cholecystitis,
             defined as right upper quadrant abdominal pain, radiological signs of cholecystitis
             (including radiological Murphy sign and/or thickened gallbladder wall and/or free
             abdominal fluid around the gallbladder) and signs of infection (including fever,
             increased CRP or white blood cell count)

          -  Age ≥ 16 years

        Exclusion Criteria:

          -  Presence of CBD stone on CT or US performed on admission (which will require ERCP
             exploration prior to surgery)

          -  Associated radiologically proven gallstone pancreatitis

          -  Associated cholangitis

          -  Medical conditions preventing surgery such as acute stroke, acute coronary syndrome,
             severe cardiac failure (NYHA class IV and/or respiratory failure with SpO2 < 85% with
             room air and/or LVEF < 35%), severe COPD with VEMS < 30 % of predicted value

          -  Medical conditions preventing informed consent

          -  Patients with contraindications to MRI (MRI-incompatible electronic devices [e.g.
             pacemakers], implants or prostheses, vascular clips less than 2 weeks, severe
             claustrophobia) and to EUS/ERCP (surgery with gastric diversion, severe cardiac
             dysfunction)
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pouya Iranmanesh, MD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT01492790

Organization ID

CER 11-045 (NAC 11-012)


Responsible Party

Principal Investigator

Study Sponsor

University Hospital, Geneva


Study Sponsor

Pouya Iranmanesh, MD, Principal Investigator, University Hospital, Geneva


Verification Date

August 2013