Crohn DiseasePANACEAPILOTNCT04623476
PAtophysiological, Nodal-based Approach for Crohn's Disease Excision
A study testing Pathophysiological Excision for Crohn's disease in people with Crohn Disease and Crohn's Ileocolitis, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence. The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Crohn's Ileocolitis
- What is being tested?
- Pathophysiological Excision for Crohn's disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2020to 30 Apr 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients undergoing surgery for ileocaecal/ileocolic CD in the Minimally Invasive Unit at Policlinico Tor Vergata are eligible to be enrolled.
- Informed consent
Who cannot join
- Crohn's Disease with a different localisation
- Recurrent disease
- Extensive jejunitis
- <18 years of age
- Cancer as primary indication for surgery
- Followed by gastroenterologists outside our centre, due to loss of follow up
- Ileostomy. If a patient undergoes ileostomy fashioning he will be excluded from the study and this will be reported
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Tor Vergata
Roma, RM, 00133
Bruno Sensi, MD, 3385352902, brunosensi@outlook.it
Giuseppe S Sica, MD, PhD, 3385333659, sigisica@gmail.com
About this study
Official title: PAtophysiological, Nodal-based Approach for Crohn's Disease Excision: A PILOT Study
Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence.
The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence.
Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease).
Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.
- Conditions
- Crohn Disease, Crohn's Ileocolitis
- Being tested
- Pathophysiological Excision for Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathophysiological Excision for Crohn's diseaseProcedure or surgery
Also called PEC
Pathophysiological excision for Crohn's (PEC) requires a medio-lateral approach and a high vascular tie, which enables excision of lymph nodes draining the disease bowel. This procedure should not alter length of bowel resection and no additional risks are foreseen. A latero-lateral anastomosis will be fashioned following current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Pathophysiological Excision for Chron's disease | Experimental | Consecutive patients (>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD Receives: Procedure: Pathophysiological Excision for Crohn's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of endoscopic CD recurrence
Endoscopic Rutgeerts score >1
Measured: 6 months
Rate of endoscopic CD recurrence
Endoscopic Rutgeerts score >1
Measured: 12 months
Secondary outcomes (8)
Rate of overall postoperative complications
Clavien Dindo I-V
Measured: 30 days
Rate of major postoperative complications
Clavien Dindo III-V
Measured: 30 days
Overall and Disease specific Quality of life
Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)
Measured: 6 months
Overall and Disease specific Quality of life
Inflammatory Bowel Disease-Control (Q 1-3 with higher scores representing better quality of life)
Measured: 6 months
Overall and Disease specific Quality of life
Cleveland Global Quality of Life score (0-1 with with higher scores representing better quality of life)
Measured: 6 months
Overall and Disease specific Quality of life
Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)
Measured: 12 months
Overall and Disease specific Quality of life
Inflammatory Bowel Disease-Control Q1-3 (0-18 with higher scores representing better quality of life)
Measured: 12 months
Overall and Disease specific Quality of life
Cleveland Global Quality of Life score (0-1 with higher scores representing better quality of life)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start16 Nov 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pilot study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
- Investigators
- Giuseppe S Sica, MD, PhD, Principal investigator, Università di Roma Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623476
- Sponsor's protocol ID
- 112/20
- Acronym
- PANACEAPILOT
- Status last verified
- Dec 2020
- First submitted
- 29 Oct 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAtophysiological, Nodal-based Approach for Crohn's Disease Excision: A PILOT Study
- ClinicalTrials.gov ID
- NCT04623476
- Acronym / sponsor ID
- PANACEAPILOT / 112/20
- Conditions
- Crohn Disease, Crohn's Ileocolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 10 Nov 2020 (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.
Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence.
The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence.
Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease).
Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Pathophysiological Excision for Chron's disease | Experimental | Procedure: Pathophysiological Excision for Crohn's diseaseConsecutive patients (>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All consecutive patients undergoing surgery for ileocaecal/ileocolic CD in the Minimally Invasive Unit at Policlinico Tor Vergata are eligible to be enrolled.
- Informed consent
Key exclusion criteria (7 listed)
- Crohn's Disease with a different localisation
- Recurrent disease
- Extensive jejunitis
- <18 years of age
- Cancer as primary indication for surgery
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 |
|---|---|---|
| Pathophysiological Excision for Crohn's diseaseAlso: PECPathophysiological excision for Crohn's (PEC) requires a medio-lateral approach and a high vascular tie, which enables excision of lymph nodes draining the disease bowel. This procedure should not alter length of bowel resection and no additional risks are foreseen. A latero-lateral anastomosis will be fashioned following current guidelines. | Procedure or surgery | Pathophysiological Excision for Chron's disease |
Primary outcome
Rate of endoscopic CD recurrence
Time frame: 6 months
Endoscopic Rutgeerts score >1
Rate of endoscopic CD recurrence
Time frame: 12 months
Endoscopic Rutgeerts score >1
8 secondary outcomes
Rate of overall postoperative complications
Time frame: 30 days
Rate of major postoperative complications
Time frame: 30 days
Overall and Disease specific Quality of life
Time frame: 6 months
Overall and Disease specific Quality of life
Time frame: 6 months
Overall and Disease specific Quality of life
Time frame: 6 months
Overall and Disease specific Quality of life
Time frame: 12 months
Overall and Disease specific Quality of life
Time frame: 12 months
Overall and Disease specific Quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- 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.
Giuseppe S Sica, MD, PhD principal investigator
Università di Roma Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathophysiological Excision for Crohn's disease in people with Crohn Disease and Crohn's Ileocolitis, run by University of Rome Tor Vergata 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 7 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: status not confirmed, as of the sponsor's last update on 28 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Sensi, MD (3385352902, brunosensi@outlook.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of endoscopic CD recurrence (time frame: 6 months). The study lists 2 primary outcomes in all. 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 28 Dec 2020.