Late Phase Acute Pancreatitis: a Tailored Step-up Approach

Several interventional and surgical procedures are available to treat moderate-to-critical acute pancreatitis (AP) in its late phase. The ongoing debate on these options, together with the scarcity of reported mid-term follow-up information in the Literature, prompted the investigators to conduct a review of our surgical experience, focused on those issues. The investigators reviewed retrospectively all the patients treated for moderate-to-critical AP according to Determinant-Based Classification (DBC), in the last nine years. Patients treated conservatively or operated within 4 weeks of the onset of the pancreatitis were excluded. All the included patients were managed following a "tailored" step-up approach, and divided into four groups, according to the first interventional procedure performed: percutaneous drainage (PD), endoscopic approach (END), internal derivation (INT), and necrosectomy (NE). In-hospital and mid-term follow-up variables, including a quality-of-life assessment, were analyzed and compared.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Sex eligibility

All sexes

Study type

Observational

About this study

The following variables were evaluated: sex, age, severity of inflammation according to the DBC classification, PA etiology, CT scan severity index according to Balthazar criteria , clinical prognostic score using bedside index of severity of acute pancreatitis (BISAP) score.

Total length of hospitalization, operative management, necrosis cultures, total and post-interventional Intensive Unit Care (ICU) were also recorded and analyzed together with the in-hospital morbidity, mortality and re-admissions.

Patients were checked after discharge within 14 days and followed monthly as outpatients by gastroenterologists. A CT scan was performed within 4 months, or before in case of recurrent symptoms. During the follow-up, the English Standard Short Form 36 (SF-36) questionnaire was used to evaluate the general quality of life at three and six months, one and two years. The SF-36 examines 8 areas consisting of social and physical function, physical and emotional well-being, bodily pain, vitality, mental health and overall general health perception. At the six-month follow-up, the patients also completed a specific questionnaire about the pancreatic function. In particular, the total score takes in consideration abdominal pain using visual analogue pain score, diarrhea, unintentional weight loss, new onset of diabetes and use of enzyme supplementation. The score ranges between zero to five (all symptoms present). The work has been reported in line with the STROCSS criteria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients treated at our referral Center for moderate to critical AP, as classified by Determinant-Based Classification of Acute Pancreatitis Severity

Exclusion criteria

patients who had undergone conservative treatment,
patients who has been operated within 4 weeks (early phase)

Treatment and study plan

percutaneous drainage

Procedure

endoscopic approach

Procedure

surgical internal derivation of WON

Procedure

surgical necrosectomy

Procedure

Primary outcomes

Satisfaction assessed by the SF-36 (36-Item Short Form Survey)

Time frame: 1 year

English Standard Short Form 36 (SF-36) questionnaire is used to evaluate the general quality of life. The SF-36 examines 8 areas consisting of social and physical function, physical and emotional well-being, bodily pain, vitality, mental health and overall general health perception. The eight scaled scores are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

A Tailored Step-up Approach for Moderate to Critical Acute Pancreatitis in the Late Phase: a Cohort Study

Acronym: TSA

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2021
First posted: May 3, 2021
Registry last updated: May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed