Late Phase Acute Pancreatitis: a Tailored Step-up Approach (TSA)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Procedure: percutaneous drainage; Procedure: endoscopic approach; Procedure: surgical internal derivation of WON; Procedure: surgical necrosectomy

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 47

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The cohort sample was divided into four groups, according to the first type of the interventional or surgical management performed

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PD group; percutaneous drainage group	Procedure: percutaneous drainage
END group; endoscopic approach group	Procedure: endoscopic approach
INT group; surgical internal derivation of WON group	Procedure: surgical internal derivation of WON
NE group; surgical necrosectomy group	Procedure: surgical necrosectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction assessed by the SF-36 (36-Item Short Form Survey)	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.	1 year

Collaborators and Investigators

• Sponsor: University of Pisa

Publications and helpful links

General Publications

• Di Candio G, Guadagni S, Furbetta N, Gianardi D, Palmeri M, Di Franco G, Bianchini M, Gambaccini D, Marciano E, Cervelli R, Marchi S, Morelli L. A "tailored" interventional and surgical management for moderate to critical acute pancreatitis in late phase: a cohort study. Langenbecks Arch Surg. 2022 Nov;407(7):2833-2841. doi: 10.1007/s00423-022-02557-x. Epub 2022 May 31.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; acute pancreatitis; surgical treatment; walled-off necrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: example-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No