Acute PancreatitisTSANCT04870268
Late Phase Acute Pancreatitis: a Tailored Step-up Approach
An observational study of Acute Pancreatitis, run by University of Pisa.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- percutaneous drainage, endoscopic approach and surgical internal derivation of WON
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to 1 Jan 2021
- How long will I take part?
- 22 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The cohort sample was divided into four groups, according to the first type of the interventional or surgical management performed
Who may be able to join
- patients treated at our referral Center for moderate to critical AP, as classified by Determinant-Based Classification of Acute Pancreatitis Severity
Who cannot join
- patients who had undergone conservative treatment,
- patients who has been operated within 4 weeks (early phase)
About this study
Official title: 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.
Read the 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
- Being tested
- percutaneous drainage, endoscopic approach, surgical internal derivation of WON, surgical necrosectomy
- Keywords
- acute pancreatitis, walled-off necrosis, surgical treatment, quality of life
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous drainageProcedure or surgery
endoscopic approachProcedure or surgery
surgical internal derivation of WONProcedure or surgery
surgical necrosectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PD group | percutaneous drainage group Receives: Procedure: percutaneous drainage | |
| END group | endoscopic approach group Receives: Procedure: endoscopic approach | |
| INT group | surgical internal derivation of WON group Receives: Procedure: surgical internal derivation of WON | |
| NE group | surgical necrosectomy group Receives: Procedure: surgical necrosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study startJan 2012
- Primary completionApr 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 47 participants (actual)
- Target duration
- 22 Months
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone guadagni, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870268
- Sponsor's protocol ID
- example-1
- Acronym
- TSA
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35639137
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Step-up Approach for Moderate to Critical Acute Pancreatitis in the Late Phase: a Cohort Study
- ClinicalTrials.gov ID
- NCT04870268
- Acronym / sponsor ID
- TSA / example-1
- Conditions
- Acute Pancreatitis
- Keywords
- acute pancreatitis, walled-off necrosis, surgical treatment, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 22 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD group | – | Procedure: percutaneous drainagepercutaneous drainage group |
| END group | – | Procedure: endoscopic approachendoscopic approach group |
| INT group | – | Procedure: surgical internal derivation of WONsurgical internal derivation of WON group |
| NE group | – | Procedure: surgical necrosectomysurgical necrosectomy group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The cohort sample was divided into four groups, according to the first type of the interventional or surgical management performed
Key inclusion criteria (1 listed)
- patients treated at our referral Center for moderate to critical AP, as classified by Determinant-Based Classification of Acute Pancreatitis Severity
Key exclusion criteria (2 listed)
- patients who had undergone conservative treatment,
- patients who has been operated within 4 weeks (early phase)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous drainage | Procedure or surgery | PD group |
| endoscopic approach | Procedure or surgery | END group |
| surgical internal derivation of WON | Procedure or surgery | INT group |
| surgical necrosectomy | Procedure or surgery | NE group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 35639137Di 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by University of Pisa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction assessed by the SF-36 (36-Item Short Form Survey) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.