search
Back to results

PAtophysiological, Nodal-based Approach for Crohn's Disease Excision (PANACEAPILOT)

Primary Purpose

Crohn Disease, Crohn's Ileocolitis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pathophysiological Excision for Crohn's disease
Sponsored by
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Policlinico Tor VergataRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pathophysiological Excision for Chron's disease

Arm Description

Consecutive patients (>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD

Outcomes

Primary Outcome Measures

Rate of endoscopic CD recurrence
Endoscopic Rutgeerts score >1
Rate of endoscopic CD recurrence
Endoscopic Rutgeerts score >1

Secondary Outcome Measures

Rate of overall postoperative complications
Clavien Dindo I-V
Rate of major postoperative complications
Clavien Dindo III-V
Overall and Disease specific Quality of life
Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)
Overall and Disease specific Quality of life
Inflammatory Bowel Disease-Control (Q 1-3 with higher scores representing better quality of life)
Overall and Disease specific Quality of life
Cleveland Global Quality of Life score (0-1 with with higher scores representing better quality of life)
Overall and Disease specific Quality of life
Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)
Overall and Disease specific Quality of life
Inflammatory Bowel Disease-Control Q1-3 (0-18 with higher scores representing better quality of life)
Overall and Disease specific Quality of life
Cleveland Global Quality of Life score (0-1 with higher scores representing better quality of life)

Full Information

First Posted
October 29, 2020
Last Updated
December 24, 2020
Sponsor
University of Rome Tor Vergata
search

1. Study Identification

Unique Protocol Identification Number
NCT04623476
Brief Title
PAtophysiological, Nodal-based Approach for Crohn's Disease Excision
Acronym
PANACEAPILOT
Official Title
PAtophysiological, Nodal-based Approach for Crohn's Disease Excision: A PILOT Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Crohn's Ileocolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pathophysiological Excision for Chron's disease
Arm Type
Experimental
Arm Description
Consecutive patients (>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD
Intervention Type
Procedure
Intervention Name(s)
Pathophysiological Excision for Crohn's disease
Other Intervention Name(s)
PEC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of endoscopic CD recurrence
Description
Endoscopic Rutgeerts score >1
Time Frame
6 months
Title
Rate of endoscopic CD recurrence
Description
Endoscopic Rutgeerts score >1
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of overall postoperative complications
Description
Clavien Dindo I-V
Time Frame
30 days
Title
Rate of major postoperative complications
Description
Clavien Dindo III-V
Time Frame
30 days
Title
Overall and Disease specific Quality of life
Description
Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)
Time Frame
6 months
Title
Overall and Disease specific Quality of life
Description
Inflammatory Bowel Disease-Control (Q 1-3 with higher scores representing better quality of life)
Time Frame
6 months
Title
Overall and Disease specific Quality of life
Description
Cleveland Global Quality of Life score (0-1 with with higher scores representing better quality of life)
Time Frame
6 months
Title
Overall and Disease specific Quality of life
Description
Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)
Time Frame
12 months
Title
Overall and Disease specific Quality of life
Description
Inflammatory Bowel Disease-Control Q1-3 (0-18 with higher scores representing better quality of life)
Time Frame
12 months
Title
Overall and Disease specific Quality of life
Description
Cleveland Global Quality of Life score (0-1 with higher scores representing better quality of life)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Sensi, MD
Phone
3385352902
Email
brunosensi@outlook.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe S Sica, MD, PhD
Phone
3385333659
Email
sigisica@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe S Sica, MD, PhD
Organizational Affiliation
Università di Roma Tor Vergata
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Tor Vergata
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Sensi, MD
Phone
3385352902
Email
brunosensi@outlook.it
First Name & Middle Initial & Last Name & Degree
Giuseppe S Sica, MD, PhD
Phone
3385333659
Email
sigisica@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PAtophysiological, Nodal-based Approach for Crohn's Disease Excision

We'll reach out to this number within 24 hrs