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Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

Primary Purpose

Crohn Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mesenteric Sparing Ileocolic Resection

High Ligation Ileocolic Resection

About this trial

This is an interventional prevention trial for Crohn Disease focused on measuring Ileocolic, Crohn's, Terminal ilium, Ileocecal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Residents of the United States
Isolated ileocolic Crohn's disease without evidence of perforation
Concurrent therapies with corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted
All patients should have undergone a colonoscopy and CT enterography in last 3 months to assess severity of disease
Have no contraindications to magnetic resonance (MR) evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
Ability to comply with protocol
Competent and able to provide written informed consent
Medically refractory disease or inability to tolerate ongoing medical therapy

Exclusion Criteria:

Inability to give informed consent.
Patients undergoing repeat ileocolic resection
Patients with concurrent disease in other locations (e.g., proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring additional operation intervention beyond an ileocolic resection
Clinically significant medical conditions within the six months before administration of Mesenchymal Stem Cells (MSCs): e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient
Specific exclusions;
a. Evidence of hepatitis B, C, or HIV
History of cancer including melanoma (with the exception of localized skin cancers)
Emergent indication for an operation
A resident outside the United States
Pregnant or breast feeding.
History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
Inability to follow up at Mayo Clinic at 3 to 4 and 12 months for postoperative imaging and endoscopy.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Mesenteric sparing ileocolic resection

High ligation ileocolic resection

Arm Description

Ileocolic resection without removal of the lymph nodes in the mesentery.

Ileocolic resection with removal of lymph nodes in the mesentery

Outcomes

Primary Outcome Measures

Number of Subjects who have Recurrence of Crohn's Disease at 6 Months

Subjects who have endoscopic or histologic evidence of recurrence

Secondary Outcome Measures

Differences in gross and histologic margins with each approach following surgery.

Determine the need for restarting immunosuppressive medication within the first year postoperatively.

Full Information

NCT ID

NCT03172143

First Posted

May 26, 2017

Last Updated

February 21, 2019

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03172143

Brief Title

Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

Official Title

Mesenteric Sparing Versus High Ligation Ileocolic Resection for the Prevention of Recurrent Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

Accrual not met

Study Start Date

August 29, 2017 (Actual)

Primary Completion Date

December 18, 2018 (Actual)

Study Completion Date

December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if taking an increased sampling of mesentery (fatty tissue next to the intestine) and lymph nodes at the time of the subject's ileocolic resection prevents a 4-6 month recurrence of Crohn's disease at the site of the new connection.

Detailed Description

Crohn's disease (CD) is a chronic inflammatory disease of the intestinal tract with an unknown etiology and an unknown cure. The characteristic transmural inflammation can progress to refractory inflammatory disease, stricturing disease, and fistulizing disease - all potential indications for surgery when medical management has been exhausted. An important tenant to remember is that surgery is not curative but is rather an adjunct to maximal medical therapy. One third of patients with CD will require a major abdominal resection within 5 years of their diagnosis, and two-thirds will ultimately require operative management at least once during the course of their disease. Unfortunately, surgery for CD is not curative and disease recurrence is common with 62% having endoscopic recurrence at six months, and 80% and 30% of patients having endoscopic and clinical recurrence, respectively, at one year. A third of these patients will require a re-operation at 10 years and up to 80% will require an additional operation by 15 years. This undoubtedly leads to an increased probability of malabsorption syndrome and decreased quality of life. A significant volume of research has been conducted in attempt to determine how to prevent postoperative recurrence of CD following an ileocolic resection. Some studies have focused on the timing of resuming postoperative medical therapy. Others have looked at surgical technique at the time of ileocolic resection including anatomic configuration of the anastomosis and performing a stapled versus handsewn anastomosis. There is recent evidence to suggest that the mesentery is actively involved in the ongoing disease process. The investigators plan to investigate if taking additional mesentery affects postoperative recurrence to support these findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

Ileocolic, Crohn's, Terminal ilium, Ileocecal

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients with Crohns Disease will be randomized in a 1:1 ratio for mesenteric sparing versus high ligation of the ileocolic artery when performing an ileocolic resection for Crohn's disease.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mesenteric sparing ileocolic resection

Arm Type

Active Comparator

Arm Description

Ileocolic resection without removal of the lymph nodes in the mesentery.

Arm Title

High ligation ileocolic resection

Arm Type

Active Comparator

Arm Description

Ileocolic resection with removal of lymph nodes in the mesentery

Intervention Type

Procedure

Intervention Name(s)

Mesenteric Sparing Ileocolic Resection

Intervention Description

In this resection, the mesentery will be spared, or left in situ during resection.

Intervention Type

Procedure

Intervention Name(s)

High Ligation Ileocolic Resection

Intervention Description

In this resection, a "high ligation" is performed, where the feeding vessel is taken at its origin in order to take sufficient mesentery and lymph nodes with the colon specimen.

Primary Outcome Measure Information:

Title

Number of Subjects who have Recurrence of Crohn's Disease at 6 Months

Description

Subjects who have endoscopic or histologic evidence of recurrence

Time Frame

6 months after surgery

Secondary Outcome Measure Information:

Title

Differences in gross and histologic margins with each approach following surgery.

Description

Determine the need for restarting immunosuppressive medication within the first year postoperatively.

Time Frame

1 year after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Residents of the United States Isolated ileocolic Crohn's disease without evidence of perforation Concurrent therapies with corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted All patients should have undergone a colonoscopy and CT enterography in last 3 months to assess severity of disease Have no contraindications to magnetic resonance (MR) evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia Ability to comply with protocol Competent and able to provide written informed consent Medically refractory disease or inability to tolerate ongoing medical therapy Exclusion Criteria: Inability to give informed consent. Patients undergoing repeat ileocolic resection Patients with concurrent disease in other locations (e.g., proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring additional operation intervention beyond an ileocolic resection Clinically significant medical conditions within the six months before administration of Mesenchymal Stem Cells (MSCs): e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient Specific exclusions; a. Evidence of hepatitis B, C, or HIV History of cancer including melanoma (with the exception of localized skin cancers) Emergent indication for an operation A resident outside the United States Pregnant or breast feeding. History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity Inability to follow up at Mayo Clinic at 3 to 4 and 12 months for postoperative imaging and endoscopy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy L Lightner, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

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