Late Phase Acute Pancreatitis: a Tailored Step-up Approach

NCT ID: NCT04870268

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2021-01-01

Brief Summary

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.

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

Conditions

Acute Pancreatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

PD group

percutaneous drainage group

percutaneous drainage

Intervention Type: PROCEDURE

END group

endoscopic approach group

endoscopic approach

Intervention Type: PROCEDURE

INT group

surgical internal derivation of WON group

surgical internal derivation of WON

Intervention Type: PROCEDURE

NE group

surgical necrosectomy group

surgical necrosectomy

Intervention Type: PROCEDURE

Interventions

percutaneous drainage

Intervention Type: PROCEDURE

endoscopic approach

Intervention Type: PROCEDURE

surgical internal derivation of WON

Intervention Type: PROCEDURE

surgical necrosectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Simone guadagni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 35639137 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

example-1

Identifier Type: -

Identifier Source: org_study_id