NCT03172143

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 29, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

May 26, 2017

Last Update Submit

February 21, 2019

Conditions

Crohn Disease

Keywords

IleocolicCrohn'sTerminal iliumIleocecal

Outcome Measures

Primary Outcomes (1)

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

    Subjects who have endoscopic or histologic evidence of recurrence

    6 months after surgery

Secondary Outcomes (1)

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

    1 year after surgery

Study Arms (2)

Mesenteric sparing ileocolic resection

ACTIVE COMPARATOR

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

Procedure: Mesenteric Sparing Ileocolic Resection

High ligation ileocolic resection

ACTIVE COMPARATOR

Ileocolic resection with removal of lymph nodes in the mesentery

Procedure: High Ligation Ileocolic Resection

Interventions

Mesenteric Sparing Ileocolic ResectionPROCEDURE

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

Mesenteric sparing ileocolic resection
High Ligation Ileocolic ResectionPROCEDURE

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.

High ligation ileocolic resection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Amy L Lightner, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2017

First Posted

June 1, 2017

Study Start

August 29, 2017

Primary Completion

December 18, 2018

Study Completion

December 18, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)