Diverticular Disease of ColonNCT07352605
Percutaneous Drainage Versus Antibiotic Therapy for Acute Diverticulitis With Abscess.
A study testing Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent lite in people with Diverticular Disease of Colon, run by Azienda Sanitaria di Firenze.
Trial summary
the management of diverticular abscesses is guided by consensus-based recommendations from the WSES guidelines, the American College of Physicians, and the American Gastroenterological Association, all of which acknowledge the predominance of anecdotal and observational evidence and the urgent need for randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease of Colon
- What is being tested?
- Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent lite
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jan 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, ≥ 18 years old.
- Patients with abdominal CT scan diagnosis of colonic AD classifiable as WSES 2A with abscess ≥4 cm and < 8 cm in size;
- Patients with haemodynamic stability at hospital admission and no clinical or radiological evidence of diffuse peritonitis.
- Patients who accept and sign the informed consent
Who cannot join
- Patients with a final diagnosis other than diverticular abscess, including those diagnosed with colonic cancer.
- Pregnancy or lactation.
- Immunosuppressed patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Percutaneous Drainage Versus Antibiotic Therapy for Acute Diverticulitis With Abscess. The PANDA Randomized Controlled Trial Pilot Study
the management of diverticular abscesses is guided by consensus-based recommendations from the WSES guidelines, the American College of Physicians, and the American Gastroenterological Association, all of which acknowledge the predominance of anecdotal and observational evidence and the urgent need for randomized controlled trials to inform clinical practice.The PANDA trial (Percutaneous drainage versus Antibiotic therapy for acute Diverticulitis with Abscess. Randomized controlled trial) is designed to address this evidence gap by directly comparing percutaneous drainage plus antibiotics versus antibiotics alone in patients with acute diverticulitis and large abscesses (WSES stage 2A). By employing strict inclusion criteria, standardized interventions, and predefined outcome measures, this study aims to clarify the relative efficacy, safety, and long-term impact of the two strategies, thereby guiding future clinical decision-making and informing guideline recommendations.
However, before we can proceed with the launch of the PANDA trial, we need to start a pilot study that will allow us to understand both the methodological and practical feasibility of starting this pilot study.
Read more
Primary objective The PANDA trial pilot study want to evaluate the local feasibility of the individual centers under study. Specifically, the primary objective will be to assess a minimum adherence rate of 70% for each participating center out of all patients with acute diverticulitis WSES 2A being evaluated. Adherence refers to the ability to enroll patients, randomize them, and perform clinical follow-up.
Secondary objectives The Panda trial pilot study want to compare the efficacy of antibiotic therapy alone versus percutaneous drainage plus antibiotic therapy in achieving complete clinical resolution at 30 days in patients with acute diverticulitis classified as WSES stage 2A, presenting with a pericolic or distant abscess ≥4 cm and < 8 cm in size.
In addition the PANDA trial pilot study wants to compare the rate of treatment failure, defined as the need for urgent surgical intervention (e.g., colectomy, resection with or without stoma formation) within 30 days.
Moreover the PANDA trial aimed to asses: the recurrence rate of diverticulitis after 90 days, defined as a new clinical episode confirmed radiologically and requiring hospital admission; to evaluate the length of hospital stay; to record and compare adverse events related to each treatment strategy, graded according to the Clavien-Dindo classification, with a focus on procedure-specific complications in the drainage arm.
Study Design
The PANDA trial pilot study is a prospective, multicentre, open-label, randomized controlled trial designed to compare two accepted non operative strategies for the management of large diverticular abscesses (WSES 2A Stage) to evaluate the methodological and structural feasibility of a national RCT. Participating centres will include high-volume emergency and general surgery units with access to both advanced interventional radiology and standardized medical management protocols. Two Intervention arms:
- Arm 1 (Control Arm) - Percutaneous drainage plus antibiotics.
- Arm 2 (Experimental Arm) - Antibiotics alone
In both arms the patients will be evaluated daily clinically and through laboratory tests.
Collaborators at each participating center will prospectively collect data for all eligible patients for 6 months followed by 3 months of follow-up.
- Conditions
- Diverticular Disease of Colon
- Being tested
- Arm 1 (Control Arm) - Percutaneous drainage plus antibiotics: Image-guided (CT or ultrasound) percutaneous drainage performed within 48 hours of randomization with intravenous bro, Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent lite
- Keywords
- Diverticulitis, Colonic diverticular abscess
- Medical subject headings
- Diverticulosis, Colonic, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 (Control Arm) - Percutaneous drainage plus antibiotics: Image-guided (CT or ultrasound) percutaneous drainage performed within 48 hours of randomization with intravenous broProcedure or surgery
CT or ultrasound-guided percutaneous drainage
Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent liteOther
Antibiotic therapy alone
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous drainage plus antibiotics. | Sham comparator | Patients with diverticular abscess greater than 4 cm in diameter who undergo percutaneous drainage and antibiotic therapy Receives: Procedure: Arm 1 (Control Arm) - Percutaneous drainage plus antibiotics: Image-guided (CT or ultrasound) percutaneous drainage performed within 48 hours of randomization with intravenous bro |
| Antibiotics alone | Experimental | Patients with diverticular abscess larger than 4 cm in diameter who are undergoing antibiotic therapy alone Receives: Other: Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent lite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
The PANDA trial pilot study want to evaluate the local feasibility of the individual centers under study. Specifically, the primary objective will be to assess a minimum adherence rate of 70% for each participating center out of all patients with acute diverticulitis WSES 2A being evaluated. Adherence refers to the ability to enroll patients, randomize them, and perform clinical follow-up.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (1)
Secondary outcomes
The Panda trial pilot study want to compare the efficacy of antibiotic therapy alone versus percutaneous drainage plus antibiotic therapy in achieving complete clinical resolution at 30 days in patients with acute diverticulitis classified as WSES stage 2A, presenting with a pericolic or distant abscess ≥4 cm and < 8 cm in size.
In addition the PANDA trial pilot study wants to compare the rate of treatment failure, defined as the need for urgent surgical intervention (e.g., colectomy, resection with or without stoma formation) within 30 days.
Moreover the PANDA trial aimed to asses: the recurrence rate of diverticulitis after 90 days, defined as a new clinical episode confirmed radiologically and requiring hospital admission; to evaluate the length of hospital stay; to record and compare adverse events related to each treatment strategy, graded according to the Clavien-Dindo classification, with a focus on procedure-specific complications in the drainage arm.
Measured: From enrollment to the end of treatment at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular Disease of ColonStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria di Firenze
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giordano, Azienda Sanitaria di Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352605
- Sponsor's protocol ID
- ASFirenze26
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Drainage Versus Antibiotic Therapy for Acute Diverticulitis With Abscess. The PANDA Randomized Controlled Trial Pilot Study
- ClinicalTrials.gov ID
- NCT07352605
- Acronym / sponsor ID
- ASFirenze26
- Conditions
- Diverticular Disease of Colon
- Keywords
- Diverticulitis, Colonic diverticular abscess
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Sanitaria di FirenzeUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
the management of diverticular abscesses is guided by consensus-based recommendations from the WSES guidelines, the American College of Physicians, and the American Gastroenterological Association, all of which acknowledge the predominance of anecdotal and observational evidence and the urgent need for randomized controlled trials to inform clinical practice.The PANDA trial (Percutaneous drainage versus Antibiotic therapy for acute Diverticulitis with Abscess. Randomized controlled trial) is designed to address this evidence gap by directly comparing percutaneous drainage plus antibiotics versus antibiotics alone in patients with acute diverticulitis and large abscesses (WSES stage 2A). By employing strict inclusion criteria, standardized interventions, and predefined outcome measures, this study aims to clarify the relative efficacy, safety, and long-term impact of the two strategies, thereby guiding future clinical decision-making and informing guideline recommendations.
However, before we can proceed with the launch of the PANDA trial, we need to start a pilot study that will allow us to understand both the methodological and practical feasibility of starting this pilot study.
Primary objective The PANDA trial pilot study want to evaluate the local feasibility of the individual centers under study. Specifically, the primary objective will be to assess a minimum adherence rate of 70% for each participating center out of all patients with acute diverticulitis WSES 2A being evaluated. Adherence refers to the ability to enroll patients, randomize them, and perform clinical follow-up.
Secondary objectives The Panda trial pilot study want to compare the efficacy of antibiotic therapy alone versus percutaneous drainage plus antibiotic therapy in achieving complete clinical resolution at 30 days in patients with acute diverticulitis classified as WSES stage 2A, presenting with a pericolic or distant abscess ≥4 cm and < 8 cm in size.
In addition the PANDA trial pilot study wants to compare the rate of treatment failure, defined as the need for urgent surgical intervention (e.g., colectomy, resection with or without stoma formation) within 30 days.
Moreover the PANDA trial aimed to asses: the recurrence rate of diverticulitis after 90 days, defined as a new clinical episode confirmed radiologically and requiring hospital admission; to evaluate the length of hospital stay; to record and compare adverse events related to each treatment strategy, graded according to the Clavien-Dindo classification, with a focus on procedure-specific complications in the drainage arm.
Study Design
The PANDA trial pilot study is a prospective, multicentre, open-label, randomized controlled trial designed to compare two accepted non operative strategies for the management of large diverticular abscesses (WSES 2A Stage) to evaluate the methodological and structural feasibility of a national RCT. Participating centres will include high-volume emergency and general surgery units with access to both advanced interventional radiology and standardized medical management protocols. Two Intervention arms:
- Arm 1 (Control Arm) - Percutaneous drainage plus antibiotics.
- Arm 2 (Experimental Arm) - Antibiotics alone
In both arms the patients will be evaluated daily clinically and through laboratory tests.
Collaborators at each participating center will prospectively collect data for all eligible patients for 6 months followed by 3 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous drainage plus antibiotics. | Sham comparator | Procedure: Arm 1 (Control Arm) - Percutaneous drainage plus antibiotics: Image-guided (CT or ultrasound) percutaneous drainage performed within 48 hours of randomization with intravenous broPatients with diverticular abscess greater than 4 cm in diameter who undergo percutaneous drainage and antibiotic therapy |
| Antibiotics alone | Experimental | Other: Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent litePatients with diverticular abscess larger than 4 cm in diameter who are undergoing antibiotic therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes, ≥ 18 years old.
- Patients with abdominal CT scan diagnosis of colonic AD classifiable as WSES 2A with abscess ≥4 cm and < 8 cm in size;
- Patients with haemodynamic stability at hospital admission and no clinical or radiological evidence of diffuse peritonitis.
- Patients who accept and sign the informed consent
Key exclusion criteria (3 listed)
- Patients with a final diagnosis other than diverticular abscess, including those diagnosed with colonic cancer.
- Pregnancy or lactation.
- Immunosuppressed patients.
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 |
|---|---|---|
| Arm 1 (Control Arm) - Percutaneous drainage plus antibiotics: Image-guided (CT or ultrasound) percutaneous drainage performed within 48 hours of randomization with intravenous broCT or ultrasound-guided percutaneous drainage | Procedure or surgery | Percutaneous drainage plus antibiotics. |
| Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent liteAntibiotic therapy alone | Other | Antibiotics alone |
Primary outcome
Primary outcome
Time frame: From enrollment to the end of treatment at 6 months
The PANDA trial pilot study want to evaluate the local feasibility of the individual centers under study. Specifically, the primary objective will be to assess a minimum adherence rate of 70% for each participating center out of all patients with acute diverticulitis WSES 2A being evaluated. Adherence refers to the ability to enroll patients, randomize them, and perform clinical follow-up.
1 secondary outcome
Secondary outcomes
Time frame: From enrollment to the end of treatment at 9 months
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 2 (Experimental Arm) - Antibiotics alone: Intravenous broad-spectrum antibiotics: piperacillin-tazobactam 4 g/0.5 g q6h (dosage to be adjusted based on renal function) according to the recent lite in people with Diverticular Disease of Colon, run by Azienda Sanitaria di Firenze.
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 4 inclusion and 3 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 20 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Contact Alessio A Giordano (00393289221689, giordanoa@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: From enrollment to the end of treatment at 6 months). 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 20 Jan 2026.