A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.

checkorphan
Learn more about:
Cholecystitis
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

A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.

Official Title

Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.

Brief Summary

      Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for
      surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in
      these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in
      treatment of this condition has been demonstrated but how the two procedures compare to one
      another is uncertain.

      The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk
      patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize
      that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Overall morbidities

Secondary Outcome

 Technical success

Condition

Acute Cholecystitis

Intervention

EUS-guided gallbladder drainage (EGBD)

Study Arms / Comparison Groups

 EUS-guided gallbladder drainage
Description:

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

60

Start Date

August 2014

Completion Date

March 2019

Primary Completion Date

February 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but are
             unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions
             including: American society of anesthesiology grading ≥ 3, APACHE score ≥ 12, limited
             life expectancy (less than 2 years) or deemed unsuitable for general anesthesia would
             be included.

          -  Written informed consent from patient or guardian who is able to understand the nature
             and possible consequences of the study

        Exclusion Criteria:

          -  Pregnancy

          -  Patients unwilling to undergo follow-up assessments

          -  Patients with suspected gangrene or perforation of the gallbladder

          -  Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated
             serum amylase more than three times the upper limit of normal)

          -  Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus,
             stomach and duodenum

          -  Patients with liver cirrhosis, portal hypertension and/or gastric varices

          -  Abnormal coagulation: INR > 1.5 and/or platelets < 50.000/mm3

          -  Previous drainage of the gallbladder

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02212717

Organization ID

CREC-2014.301-T

Responsible Party

Principal Investigator

Study Sponsor

Chinese University of Hong Kong

Collaborators

 American Society for Gastrointestinal Endoscopy

Study Sponsor

, ,

Verification Date

July 2019