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

Sponsor

University of Pisa (Other)

Overall Status

Completed

CT.gov ID

NCT04870268

Collaborator

(none)

Enrollment

108

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pancreatitis	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

47 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Pisa

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Mar 31, 2021

More Information

Publications

None provided.

Responsible Party:

Simone guadagni, Principal Investigator, University of Pisa

ClinicalTrials.gov Identifier:

NCT04870268

Other Study ID Numbers:

example-1

First Posted:

May 3, 2021

Last Update Posted:

May 3, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Simone guadagni, Principal Investigator, University of Pisa

Additional relevant MeSH terms:

Pancreatitis

Study Results

No Results Posted as of May 3, 2021