The Landscape of Acute Pancreatitis Trials Registered in ClinicalTrials.gov: A Cross-sectional Study

Pancreas. 2022 May 1;51(5):445-451. doi: 10.1097/MPA.0000000000002051. Epub 2022 Jul 16.

Abstract

Objectives: Clinical studies are important in informing evidence-based practice for patients with acute pancreatitis (AP). To determine whether registered studies adequately meet this need, we leveraged the ClinicalTrials.gov database to provide an overview of studies pertaining to AP.

Methods: ClinicalTrials.gov was searched and the search term used was AP. Analysis was restricted to studies registered before January 12, 2021.

Results: Of 363,632 trials overall, 234 (0.06%) were eventually included for analysis. Interventional studies and observational studies comprised 67.5% and 32.5% of these studies respectively. Most studies were initiated 2007 or later. Endoscopic retrograde cholangiopancreatography was the single most frequent cause of AP specified in these studies (16.7%). Nearly 72% of these studies had a sample size greater than 50. With respect to study design, 87.3% of interventional studies were randomized, 53.5% were blinded. The top 3 countries with the largest number of registered studies were China (n = 59), followed by the United States (n = 53) and India (n = 12).

Conclusions: Our results indicate that the research activity falls short of what is needed in terms of the burden of AP. The distribution of these AP-related studies by global regions indicates that there exists regional disparities.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Cholangiopancreatography, Endoscopic Retrograde / methods
  • Cross-Sectional Studies
  • Humans
  • Observational Studies as Topic
  • Pancreatitis* / diagnosis
  • Pancreatitis* / therapy
  • Randomized Controlled Trials as Topic
  • Sample Size
  • United States / epidemiology