DiverticulitisDIVENDONCT07027007
Prospective Observational Analysis of Circulating Endocan Levels in Patients Presenting With Acute Diverticulitis
An observational study of Diverticulitis, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial summary
Quantify the level of endocan in blood samples collected from patients with acute diverticulitis in the emergency department. Determine if endocan levels are correlated with the severity of diverticulitis according to the WSES classification. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diverticulitis
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2025to Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by acute diverticulitis in the emergency department
Who may be able to join
- Patients who have signed informed consent
- Patients who are affected by acute diverticulitis after clinical evaluation and imaging (i.e. u.s. or CeCT)
Who cannot join
- Immunosuppressed patients
- Patients suffering chronic inflammatory diseases
- Patients with concomitant malignancy, cardiac, renal and haepatic failure
- History of major vascular surgery (aneurysmectomy)
- Pregnant women
- Patients participating in other studies that may interfere with the outcome of the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Emergency Department IRCCS San Raffaele
Milan, milano, 20132
Luca Ghirardelli, MD, +393282342663, ghirardelli.luca@hsr.it
Luca Ghirardelli, MD
About this study
Quantify the level of endocan in blood samples collected from patients with acute diverticulitis in the emergency department. Determine if endocan levels are correlated with the severity of diverticulitis according to the WSES classification. Assess whether patients requiring emergency surgical intervention have higher endocan values compared to others.
- Conditions
- Diverticulitis
- Keywords
- endocan, acute diverticolitis, diverticulitis classification
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute diverticulitis | Patients admitted to the emergency department with acute diverticulitis classified according to WSES statements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocan serum level at admission
To evaluate the correlation between blood concentration of endocan and severity of diverticulitis
Measured: The serum of the patients enrolled inthe study will be collected within two hours from emergency room registation and tested for ENDOCAN
Secondary outcomes (2)
Predictive value of endocan in determining which patients need emergency surgery
Concentration of endocan in grade 3-4 WSES compared to grade1-2
Measured: Patients will undergo diverticulitis evaluations (per WSES criteria) within 3 hours of Emergency room admission and study enrollment
Prognostic value of endocan in determining the risk of recurrent diveritculitis
Concentration of endocan in patient who develop a recurrence after 1 year follow-up
Measured: From discharge after definitive tretament till 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start30 Sep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ghirardelli, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027007
- Sponsor's protocol ID
- DIVENDO STUDY
- Acronym
- DIVENDO
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Analysis of Circulating Endocan Levels in Patients Presenting With Acute Diverticulitis
- ClinicalTrials.gov ID
- NCT07027007
- Acronym / sponsor ID
- DIVENDO / DIVENDO STUDY
- Conditions
- Diverticulitis
- Keywords
- endocan, acute diverticolitis, diverticulitis classification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Jun 2025 (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.
Quantify the level of endocan in blood samples collected from patients with acute diverticulitis in the emergency department. Determine if endocan levels are correlated with the severity of diverticulitis according to the WSES classification. Assess whether patients requiring emergency surgical intervention have higher endocan values compared to others.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute diverticulitis | – | –Patients admitted to the emergency department with acute diverticulitis classified according to WSES statements. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by acute diverticulitis in the emergency department
Key inclusion criteria (2 listed)
- Patients who have signed informed consent
- Patients who are affected by acute diverticulitis after clinical evaluation and imaging (i.e. u.s. or CeCT)
Key exclusion criteria (6 listed)
- Immunosuppressed patients
- Patients suffering chronic inflammatory diseases
- Patients with concomitant malignancy, cardiac, renal and haepatic failure
- History of major vascular surgery (aneurysmectomy)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endocan serum level at admission
Time frame: The serum of the patients enrolled inthe study will be collected within two hours from emergency room registation and tested for ENDOCAN
To evaluate the correlation between blood concentration of endocan and severity of diverticulitis
2 secondary outcomes
Predictive value of endocan in determining which patients need emergency surgery
Time frame: Patients will undergo diverticulitis evaluations (per WSES criteria) within 3 hours of Emergency room admission and study enrollment
Prognostic value of endocan in determining the risk of recurrent diveritculitis
Time frame: From discharge after definitive tretament till 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocan serum level at admission (time frame: The serum of the patients enrolled inthe study will be collected within two hours from emergency room registation and tested for ENDOCAN). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.