Late Phase Acute Pancreatitis: a Tailored Step-up Approach

NCT04870268 | Completed

• 1 other identifier: example-1
• Study Type: observational
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Pancreatitis

Keywords

acute pancreatitis; walled-off necrosis; surgical treatment; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Interventions

percutaneous drainage PROCEDURE

PD group

endoscopic approach PROCEDURE

END group

surgical internal derivation of WON PROCEDURE

INT group

surgical necrosectomy PROCEDURE

NE group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pisa: lead

Related Publications (1)

• 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.

  PMID: 35639137 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 22 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 3, 2021
• Study Start: January 1, 2012
• Primary Completion: April 1, 2020
• Study Completion: January 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share