Proactive graded follow-up strategy for reducing recurrence in acute pancreatitis (PROGRESS): protocol for a multicentre, randomised controlled trial.

Abstract

Recurrence of acute pancreatitis (AP) is common, leading to cumulative pancreatic injury and reduced quality of life. While aetiology-based treatments and lifestyle interventions are effective, long-term adherence is often poor due to insufficient health awareness and a lack of continuous reminders. We designed the PROGRESS (<i>PRO</i>active <i>GR</i>ad<i>E</i>d follow-up <i>S</i>trategy for reducing recurrence in acute pancreatiti<i>S</i>) trial to evaluate whether a physician-initiated, proactive and graded follow-up strategy can reduce AP recurrence. The PROGRESS trial is a multicentre, open-label, randomised controlled trial. A total of 194 patients with AP will be randomised 1:1 to either a proactive follow-up group or a standard follow-up group. In the proactive follow-up group, patients are stratified into high-risk or low-risk categories based on reported risk factors. Follow-up is conducted via WeChat with varying frequencies: every 3 months for the high-risk group and every 6 months for the low-risk group. The standard follow-up group receives routine discharge education and a 1-month outpatient visit. The primary endpoint is the number of AP recurrence episodes within 24 months post-discharge. Secondary endpoints include AP recurrence rate, progression to chronic pancreatitis, quality of life (Short Form 12 Health Survey), anxiety/depression scores (Generalized Anxiety Disorder-7/Patient Health Questionnaire-9), readmission rates and mortality. Analysis will follow the intention-to-treat principle. This study has been approved by the Ethics Committee of Peking Union Medical College Hospital (No. I-25PJ2556, I-26PJ0895). Ethics approval of each participating centre is required before initiation of patient enrolment. The results of this study will be published in peer-reviewed journals. ChiCTR2500113459 (Chinese Clinical Trial Registry).