A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine As Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP): Interim Analysis Results

Background and study aimsPost-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.Patients and methodsThis multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.ResultsOf the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).ConclusionSpraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.Trial registration numberThis study was registered with ClinicalTrials.gov (NCT02959112).

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Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients with Gallbladder Stones and Intermediate Risk for Choledocholithiasis: Study Protocol for a Diagnostic Randomized Trial

10.21203/rs.2.9929/v2 ◽

2020 ◽

Author(s):

Ausra Aleknaite ◽

Gintaras Simutis ◽

Juozas Stanaitis ◽

Tomas Jucaitis ◽

Mantas Drungilas ◽

...

Keyword(s):

Laparoscopic Cholecystectomy ◽

Endoscopic Retrograde Cholangiopancreatography ◽

Endoscopic Ultrasound ◽

Management Strategies ◽

Endoscopic Retrograde Cholangiography ◽

Intraoperative Cholangiography ◽

Intermediate Risk ◽

Endoscopic Retrograde ◽

On Demand ◽

Gallbladder Stones

Abstract Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancreatography should be minimized as it carries considerable risk of post-procedural complications. This study compares two different management strategies: intraoperative cholangiography and endoscopic ultrasound before laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis. Methods: It is a diagnostic randomized active-controlled single-centre clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment. Discussion: This trial is planned determine which strategy is better approach for a patient with intermediate common bile duct stones risk and to define a simple to calculate and safe algorithm on managing choledocholithiasis. Trial registration: The trial is registered at ClinicalTrials.gov, identification number NCT03658863.

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Study protocol for a multicentre, randomised controlled trial of the external use of mirabilite to prevent pancreatitis in children after endoscopic retrograde cholangiopancreatography.

10.21203/rs.3.rs-20402/v1 ◽

2021 ◽

Author(s):

Zhaohui Deng ◽

Biao Gong ◽

Kaihua Yang ◽

Jingqing Zeng ◽

Chan Lv ◽

...

Keyword(s):

Acute Pancreatitis ◽

Endoscopic Retrograde Cholangiopancreatography ◽

Controlled Trial ◽

Intestinal Barrier ◽

Basic Research ◽

Intestinal Barrier Function ◽

Therapeutic Effects ◽

Endoscopic Retrograde ◽

Clinical Benefits ◽

Randomised Controlled

Abstract Background Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP) in children. To date, there is no suitable medicine for post-ERCP pancreatitis prophylaxis in children and few study has prospectively evaluated an intervention to prevent post-ERCP pancreatitis in children. Mirabilite, a well-known traditional Chinese medicine(TCM) has good therapeutic effects on acute pancreatitis and no side effect for children by basic research and clinical studies. Our protocol is designed to assess the efficacy and safety of the external use of mirabilite to prevent post-ERCP pancreatitis in children. Methods/design: 520 patients planned for diagnostic and therapeutic ERCP will be enrolled according to the eligibility criteria‎. The patients will be randomly divided into two equal groups (Mirabilite and control, the external use of mirabilite in a bag on the projected abdominal area over the pancreas within 30 min before ERCP). The primary end point is incidence of post-ERCP pancreatitis. Secondary end points include abdominal pain scores, the levels of inflammatory markers [tissue necrosis factor (TNF)-α, IL-6, and IL-8] and intestinal barrier function markers (diamine oxidase, D-lactic acid, and endotoxin). Additionally, the side effects of topical mirabilite is investigated. Conclusion This trial would be the first experiment to determine mirabilite to prevent post-ERCP pancreatitis in children. Mirabilite maybe provide potential clinical benefits and a new avenue with tremendous potential for the future preventing of post-ERCP pancreatitis. Trial registration number: ChiCTR1900022642. Registered on 19 April 2019- Retrospectively registered, http://www.chictr.org.cn.

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Comparing cost-effectiveness between endoscopic ultrasound and endoscopic retrograde cholangiopancreatography in diagnosis of common bile duct stone in patients with predefined risks: A study from a developing country

Endoscopic Ultrasound ◽

10.4103/2303-9027.183971 ◽

2016 ◽

Vol 5 (3) ◽

pp. 165 ◽

Cited By ~ 7

Author(s):

Nisa Netinatsunton ◽

Siriboon Attasaranya ◽

Jaksin Sottisuporn ◽

Teepawit Witeerungrot ◽

Theeratus Jongboonyanuparp ◽

...

Keyword(s):

Cost Effectiveness ◽

Bile Duct ◽

Common Bile Duct ◽

Developing Country ◽

Endoscopic Retrograde Cholangiopancreatography ◽

Endoscopic Ultrasound ◽

Common Bile Duct Stone ◽

Bile Duct Stone ◽

Endoscopic Retrograde

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Comparison of Recovery Time of Propofol and Midazolam with Propofol Alone for Sedation in Endoscopic Retrograde Cholangiopancreatography

10.53350/pjmhs211551024 ◽

2021 ◽

Vol 15 (5) ◽

pp. 1024-1027

Author(s):

Asma Samreen ◽

Aamir Waseem ◽

Muhammad Azam ◽

Itrat Hussain Kazmi ◽

Aamir Bashir ◽

...

Keyword(s):

Endoscopic Retrograde Cholangiopancreatography ◽

Recovery Time ◽

Controlled Trial ◽

P Value ◽

Time Data ◽

Endoscopic Retrograde ◽

Intravenous Anesthetic ◽

Significant Difference ◽

Group A ◽

Group B

Background: Procedural sedation is required for multiple short duration procedures outside of the operating rooms especially in radiology and endoscopy suites. Intravenous anesthetic agent with rapid recovery profile is desirable in such circumstances. This study aims to compare two regimens of intravenous anesthetic agents. Aim: To compare the mean recovery time of propofol and midazolam with propofol alone for sedation in endoscopic retrograde cholangiopancreatography. Study Design: Randomized controlled trial. Settings: Department of Anesthesia, Shalamar Hospital, Lahore. Study Duration: June 2017 to December 2017. Methods: A total of 70 adult patients aged 20-60 years undergoing ERCP under sedation were included. Patients were given a combination of propofol and midazolam in group A while propofol alone was given in group B. After procedure, pts were transferred to recovery room and were followed for assessment of recovery time. Data were analyzed in SPSS vr 21, Independent t-test was applied & p-value ≤0.05 was considered statistically significant. Results: Significant difference was found in mean recovery time amongst both the groups. Mean recovery time in Group A (propofol and midazolam) was 19.29±4.50 minutes while in Group B (propofol alone) was 26.66±3.70 minutes showing statistically significant result with p-value = 0.0001. Conclusion: We conclude that mean recovery time with propofol plus midazolam is shorter as compared to propofol alone for sedation in ERCP. Keywords: Propofol, midazolam, sedation outside operation theatre.

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