Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05211206
Other study ID # REB21-1885
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 10, 2022
Est. completion date February 28, 2026

Study information

Verified date December 2023
Source University of Calgary
Contact Nauzer Forbes, MD MSc
Phone 403-592-5089
Email nauzer.forbes@ucalgary.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aggressive intravenous hydration has been shown in randomized trials to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), though studied regimens are often impractical. To date, no studies have prospectively assessed short-term (60-90 minute) aggressive hydration regimens that are feasible for outpatients undergoing ERCP and subsequent discharge. Furthermore, little is known with regard to fluid type, volume, and timing with respect to ERCP. In this study, we will aim to assess whether the amount of peri-procedural intravenous fluid administered around the time of ERCP is associated with the risk of PEP (the primary outcome).


Description:

1. Background and Rationale While very effective, endoscopic retrograde cholangiopancreatography (ERCP) is widely known to have the highest adverse event (AE) profile among all commonly performed endoscopic procedures, with a collective AE rate of >10%. Common AEs include post-ERCP pancreatitis (PEP), bleeding, cholangitis, cholecystitis, perforation, and cardiopulmonary events. PEP is the most common, with estimated rates of 5-10%. It is noteworthy that both the incidence of PEP and its associated mortality are rising. It is of critical priority to patients, practitioners, and health administrators to investigate factors associated with all AEs and unplanned healthcare encounters (UHEs) following ERCP, especially given that most ERCPs are performed on an outpatient basis. The per-admission costs of post-ERCP UHEs are substantial, exceeding $10,000 and $70,000 for pancreatitis and cholangitis, respectively. PEP alone accounts for an estimated $200+ million in annual healthcare spending in the United States. Thus, researchers must prioritize the study of ERCP outcomes, striving to both identify and modify factors leading to AEs and UHEs. Peri-procedural fluid management and its relationship with ERCP outcomes also remains incompletely understood. Aggressive intravenous hydration (AH) has been shown to reduce the risk of PEP compared with standard peri-procedural hydration regimens. However, all AH regimens studied to date involve continuous hydration for 8-24 hours, which is impractical and thus non-generalizable to almost all North American outpatient ERCPs practices. To date, no studies have prospectively assessed short-term (60-90 minute) aggressive hydration regimens that are feasible for outpatients undergoing ERCP and subsequent discharge. Furthermore, little is known with regard to fluid type, volume, and timing with respect to ERCP. 2. Research Question and Objectives In this study, we will aim to assess whether the amount of peri-procedural intravenous fluid administered around the time of ERCP is associated with the risk of PEP (the primary outcome). 3. Methods Design: This is a retrospective cohort study where all data used to answer the proposed research question will be obtained from research data previously collected under REB18-0410. REB18-0410 (CReATE) is a multicenter prospective cohort study that recruits patients undergoing ERCP during which various relevant clinical and patient demographic data have been collected. The objective of REB18-0410 is to determine the clinical effectiveness and adverse event profile of ERCP. The exposure variable for this study will be a the total peri-procedural IV fluid volume administered, measured and reported as a continuous variable. In addition to these variables, other parameters we will assess include: the presence and timing of pharmacologic PEP prophylaxis, extent and timing of trainee involvement, the number and timing of common bile duct (CBD) cannulation attempts, the depth, timing, trajectory and number of PD cannulation(s), the presence and extent of PD opacification, the size(s) of sphincterotomy and/or sphincteroplasty, intra-procedural pathology, and the composition, caliber and length of any PD or CBD stent(s). Outcomes: The primary outcome will be PEP, using established definitions. Secondary outcomes (defined a priori) will include PEP severity, overall and specific AEs (bleeding, cholangitis, cardio-pulmonary events), cannulation time and success rate, as well as overall procedure time and success rate. Sample Size and Power: Using a cutoff of a total peri-procedural IV fluid volume of ≥ 2 L (versus < 1 L), a minimum of 1,530 patients are anticipated to meet the exposure definition, with an anticipated 12,750 patients that will meet the control definition. We will be able to demonstrate increases in PEP risk from 5.0% to 6.8% (a relative increase of 36%) with 82.3% power or from 5.0% to 7.0% (a relative increase of 40%) with 88.6% power. Statistical Analysis: Variables will be compared using Student's t-test for measured variables and chi-squared test for categorical variables. P values < 0.05 will be considered significant. We will use multivariable logistic regression to assess associations between risk factors and having PEP versus not having PEP. Clinically relevant subgroup analyses will also be performed by relevant patient-, endoscopist-, and procedure-related characteristics. Odds ratios per outcome will be reported with 95% CIs.


Recruitment information / eligibility

Status Recruiting
Enrollment 13000
Est. completion date February 28, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject referred for ERCP, regardless of indication; - Subject age 18 years or older; - Subject able to give informed consent to involvement be included. Exclusion Criteria: - Subject has a standard contraindication to ERCP; - Subject or surrogate unable or unwilling to provide informed consent; - Subject age < 18 years.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
IV fluids
Amount of intravenous fluids delivered

Locations

Country Name City State
Canada Peter Lougheed Hospital Calgary Alberta

Sponsors (6)

Lead Sponsor Collaborator
University of Calgary Halton Health (Oakville), Island Health, Victoria, BC, McGill University, Queen's University, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary post-ERCP pancreatitis Number of participants with any 2 of: (1) epigastric abdominal pain, (2) serum amylase/lipase >3x the upper limit of normal, (3) imaging findings consistent with acute pancreatitis 30 days
See also
  Status Clinical Trial Phase
Completed NCT02041390 - Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases N/A
Completed NCT04619511 - Risk Factors for Post-ESWL and Post-ERCP Pancreatitis
Terminated NCT00419549 - Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP) Phase 2/Phase 3
Recruiting NCT04255095 - Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis N/A
Completed NCT05220774 - Conscious Sedation Versus Anesthesia for ERCP
Completed NCT03698266 - Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs? N/A
Recruiting NCT03350555 - Clinical Trials to Validate the Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography N/A
Completed NCT04671095 - Single Use ERCP Performance -SURE Study
Recruiting NCT05603702 - STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis Phase 1
Recruiting NCT04447976 - Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice
Completed NCT03185390 - Periampullary Lesions Via ERCP in Assuit University Hospital N/A
Enrolling by invitation NCT03416205 - A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP N/A
Not yet recruiting NCT04658212 - A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis N/A
Recruiting NCT04661332 - Registry of Endoscopic Retrograde Cholangiopancreatographies Performed in Humans
Terminated NCT02046590 - RCT of Efficacy and Safety of Sedation Compared to General Anesthesia for ERCP N/A
Recruiting NCT05219123 - Guidewire Management in ERCP
Completed NCT00731198 - Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP) Phase 3
Completed NCT04167592 - Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP N/A
Completed NCT01873079 - PPI for Prevention of Post-sphincterotomy Bleeding Phase 3
Not yet recruiting NCT05225909 - aScope Single Use ERCP Study- ASSURE Study