Crohn DiseaseNCT03172143
Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease
A study testing Mesenteric Sparing Ileocolic Resection and High Ligation Ileocolic Resection in people with Crohn Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Mesenteric Sparing Ileocolic Resection and High Ligation Ileocolic Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 18 Dec 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
- Evidence of hepatitis B, C, or HIV
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Mesenteric Sparing Versus High Ligation Ileocolic Resection for the Prevention of Recurrent Crohn's Disease
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Mesenteric Sparing Ileocolic Resection, High Ligation Ileocolic Resection
- Keywords
- Ileocolic, Crohn's, Terminal ilium, Ileocecal
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenteric Sparing Ileocolic ResectionProcedure or surgery
In this resection, the mesentery will be spared, or left in situ during resection.
High Ligation Ileocolic ResectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Mesenteric sparing ileocolic resection | Active comparator | Ileocolic resection without removal of the lymph nodes in the mesentery. Receives: Procedure: Mesenteric Sparing Ileocolic Resection |
| High ligation ileocolic resection | Active comparator | Ileocolic resection with removal of lymph nodes in the mesentery Receives: Procedure: High Ligation Ileocolic Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects who have Recurrence of Crohn's Disease at 6 Months
Subjects who have endoscopic or histologic evidence of recurrence
Measured: 6 months after surgery
Secondary outcomes (1)
Differences in gross and histologic margins with each approach following surgery.
Determine the need for restarting immunosuppressive medication within the first year postoperatively.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start29 Aug 2017
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Why it stopped: Accrual not met
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy L Lightner, Mayo Clinic
- Investigators
- Amy L Lightner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172143
- Sponsor's protocol ID
- 16-008144
- Status last verified
- Feb 2019
- First submitted
- 26 May 2017
- Last updated
- 25 Feb 2019
- 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 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenteric Sparing Versus High Ligation Ileocolic Resection for the Prevention of Recurrent Crohn's Disease
- ClinicalTrials.gov ID
- NCT03172143
- Acronym / sponsor ID
- 16-008144
- Conditions
- Crohn Disease
- Keywords
- Ileocolic, Crohn's, Terminal ilium, Ileocecal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual not met
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 1 Jun 2017 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mesenteric sparing ileocolic resection | Active comparator | Procedure: Mesenteric Sparing Ileocolic ResectionIleocolic resection without removal of the lymph nodes in the mesentery. |
| High ligation ileocolic resection | Active comparator | Procedure: High Ligation Ileocolic ResectionIleocolic resection with removal of lymph nodes in the mesentery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
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 |
|---|---|---|
| Mesenteric Sparing Ileocolic ResectionIn this resection, the mesentery will be spared, or left in situ during resection. | Procedure or surgery | Mesenteric sparing ileocolic resection |
| High Ligation Ileocolic ResectionIn 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. | Procedure or surgery | High ligation ileocolic resection |
Primary outcome
Number of Subjects who have Recurrence of Crohn's Disease at 6 Months
Time frame: 6 months after surgery
Subjects who have endoscopic or histologic evidence of recurrence
1 secondary outcome
Differences in gross and histologic margins with each approach following surgery.
Time frame: 1 year after surgery
Results and safety
The study was stopped early (reason given: Accrual not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Amy L Lightner, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenteric Sparing Ileocolic Resection and High Ligation Ileocolic Resection in people with Crohn Disease, run by Mayo Clinic at 1 site in United States.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Feb 2019. 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 United States. 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?
The study was stopped early (reason given: Accrual not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects who have Recurrence of Crohn's Disease at 6 Months (time frame: 6 months after surgery). 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 25 Feb 2019.