Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

Mayo Clinic

Status: Terminated

Conditions: Crohn Disease

Treatments: Procedure: High Ligation Ileocolic Resection; Procedure: Mesenteric Sparing Ileocolic Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT03172143

16-008144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Inability to give informed consent.

2. Patients undergoing repeat ileocolic resection

3. 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

4. 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

5. Specific exclusions;

   a. Evidence of hepatitis B, C, or HIV

6. History of cancer including melanoma (with the exception of localized skin cancers)

7. Emergent indication for an operation

8. A resident outside the United States

9. Pregnant or breast feeding.

10. History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity

11. Inability to follow up at Mayo Clinic at 3 to 4 and 12 months for postoperative imaging and endoscopy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Mesenteric sparing ileocolic resection

Active Comparator group

Description:

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

Treatment:

Procedure: Mesenteric Sparing Ileocolic Resection

High ligation ileocolic resection

Active Comparator group

Description:

Ileocolic resection with removal of lymph nodes in the mesentery

Treatment:

Procedure: High Ligation Ileocolic Resection