P4480 - Trends and Design Aspects of Ongoing ERCP Clinical Research – Analysis of Studies Registered in U.S. Clinical Trial Registry

Akanksha Togra, MD¹, Jose W. Sotelo, MD¹, Neil Sheth, MD², Phong T. Nguyen, MD, MPH, MSN³, Brian Lee, DO¹, Swati Mahapatra, DO¹, Ricardo Badillo, MD^4
1Texas Tech University Health Sciences Center, El Paso, TX; ²University of Texas at Houston, Houston, TX; ³William Beaumont Army Medical Center, El Paso, TX; ⁴TTUHSC, El Paso, TX

Introduction: Endoscopic retrograde cholangiopancreatography (ERCP) plays a vital role in the management of biliary and pancreatic disorders by providing diagnostic and therapeutic value. Clinical trials in ERCP develop and validate new techniques, technologies and procedural protocols to enhance its efficacy and minimize complications. We analyzed trends in ERCP clinical studies registered in ClinicalTrials.gov (CTG) to understand the ongoing research.

Methods: ERCP related clinical studies registered in CTG from September 27, 2007 to May 30, 2024 were identified using the ‘Advanced Search’ feature in the CTG website. Trial trends and design aspects were assessed. Frequency calculations, odds ratio and 95% confidence intervals were determined.

Results: A total of 550 ERCP clinical studies were registered in CTG, which included 383 (69.64%) interventional and 167 (30.36%) observational studies with patient registries constituting 5.63% of total ERCP studies initiated. Ongoing 121 ERCP studies constitute 22% of total ERCP studies.

Of 121 ongoing ERCP studies, there were 77 (63.6%) interventional and 44 (36.4%) observational studies, with active ERCP registry studies constituting 10.74%. A higher proportion of ongoing ERCP registry studies was observed compared with proportion of total ERCP registries (OR 2.02; 95% CI: 1.02 to 3.98; P < 0.05). Similar analysis comparing the proportion of ongoing ERCP registries to total registries on CTG was also significantly higher (OR 2.67; 95% CI: 1.50 to 4.74; P < 0.001).

Assessment of key attributes of clinical design revealed primary objectives of 57 studies (47.11%) were to assess efficacy, 47 studies (38.84%) were assessing safety and complications of ERCP and 17 studies (15.05%) were focusing on diagnosis and disease progression. Majority of 77 interventional studies are RCTs with different level of blinding (50.65%), RCTs with no blinding are 38.96% and 10.39% studies were single arm studies. Around 19.88% of ongoing 121 ERCP clinical studies are being conducted for neoplastic conditions, 55.37% for non-neoplastic pancreaticobiliary disease and 24.70% focusing on ERCP procedures, involving new techniques and technologies with ERCP.

Discussion: ERCP has been around for almost 60 years and yet new technique and technologies are constantly being incorporated for increasing effectiveness. Currently, there is an emphasis on registry studies in ERCP. Robust clinical studies are required to generate evidence for adoption of newer technologies.


Disclosures:


Akanksha Togra, MD¹, Jose W. Sotelo, MD¹, Neil Sheth, MD², Phong T. Nguyen, MD, MPH, MSN³, Brian Lee, DO¹, Swati Mahapatra, DO¹, Ricardo Badillo, MD⁴. P4480 - Trends and Design Aspects of Ongoing ERCP Clinical Research – Analysis of Studies Registered in U.S. Clinical Trial Registry, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.