<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02193802</url>
  </required_header>
  <id_info>
    <org_study_id>GETAID 2012-3</org_study_id>
    <secondary_id>2013-A00034-41</secondary_id>
    <nct_id>NCT02193802</nct_id>
  </id_info>
  <brief_title>Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease</brief_title>
  <acronym>CHANCE</acronym>
  <official_title>Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been&#xD;
      demonstrated in a number of studies.&#xD;
&#xD;
      Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of&#xD;
      small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not&#xD;
      complete since it does not allow exploration of the small bowel beyond the terminal ileum&#xD;
      (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crohn's disease is a chronic, inflammatory disorder affecting any part of the&#xD;
      gastrointestinal tract but the terminal ileum is the most frequent location involved alone or&#xD;
      in combination with other locations. While about one half of patients have involvement of the&#xD;
      ileum and large bowel, another third have disease limited to the small bowel.&#xD;
&#xD;
      The disease affects populations around the globe and occurs at any age but tends to have a&#xD;
      peak incidence between the ages of 15 and 35. Typical presenting symptoms include abdominal&#xD;
      pain and diarrhea. The clinical presentation of Crohn's disease fluctuates throughout the&#xD;
      course of the disease. Symptoms and signs usually correlate with mucosal inflammation. The&#xD;
      pattern of Crohn's disease viewed on endoscopy has been characterized and is associated with&#xD;
      a number of mucosal characteristics such as erythema, swelling, nodularity, strictures,&#xD;
      aphthoid ulceration and ulcers of variable size and depth.&#xD;
&#xD;
      The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been&#xD;
      demonstrated in a number of studies. Diagnostic yields of 70% have been reported in suspected&#xD;
      SB Crohn's disease. In patients with a known Crohn's disease, the superiority of the capsule&#xD;
      to detect mucosal lesions of the SB in comparison to any other radiologic technique has also&#xD;
      been clearly demonstrated.&#xD;
&#xD;
      A number of studies indicate that mucosal healing is a good predictor of long term remission.&#xD;
      In particular, intense therapeutic regimens including purine analogues and biologic therapies&#xD;
      like infliximab have been associated with endoscopic mucosal healing. The recently published&#xD;
      SONIC trial evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy and&#xD;
      the two drugs combined in moderate to severe Crohn's disease patients. Patients who were&#xD;
      treated with infliximab monotherapy and with the combination therapy had significantly longer&#xD;
      corticosteroid-free clinical remission than those receiving azathioprine alone. Furthermore,&#xD;
      mucosal healing, defined as the absence of mucosal ulcerations at week 26, was greater for&#xD;
      the combination therapy than each of the monotherapies alone. Based on the results of these&#xD;
      studies, obtaining a mucosal healing becomes in clinical practice a new therapeutic objective&#xD;
      especially in patients treated by immunosuppressors or anti-TNF-alpha antibodies. In most of&#xD;
      the studies, a complete mucosal healing was assessed by the complete disappearance of&#xD;
      ulceration. An endoscopic response could be evaluated by the variation of several endoscopic&#xD;
      scores of severity, that are either dedicated to the terminal ileon (TI) more the colon i.e.&#xD;
      the Crohn's disease endoscopic severity index (CDEIS) or to the SB i.e. the Lewis score.&#xD;
      Concerning the evaluation of the mucosal lesions of the SB by the capsule, a new index of&#xD;
      severity is being developed in a study conducted by the different centers of the GETAID i.e.&#xD;
      the CE-CDEIS. This score will be available in the first semester of 2013 and would be usable&#xD;
      for the present study.&#xD;
&#xD;
      Unfortunately, the assessment of mucosal healing by conventional ileocolonoscopy is not&#xD;
      complete since it does not allow exploration of the small bowel beyond TI. Thus, while&#xD;
      mucosal changes and symptomatic improvement in subjects with SB Crohn's disease (with or&#xD;
      without colonic involvement) can be inferred from studies like ACCENT I, direct evidence of&#xD;
      the healing of the majority of the small bowel is lacking. In addition, correlation between&#xD;
      evidence of mucosal healing and symptoms, as measured by the Crohn's Disease Activity Index&#xD;
      (CDAI), has not been found reliable. This may reflect the limitation of viewing the full&#xD;
      extent of small bowel ulcerations on the limited examination which is possible with&#xD;
      ileocolonoscopy. This may potentially be overcome with the use of capsule endoscopy of the&#xD;
      small bowel.&#xD;
&#xD;
      Until now, no study has evaluated the potential treatment-induced changes of the mucosal&#xD;
      lesions located in the SB with a capsule and no comparison between the capsule and the&#xD;
      ileocolonoscopy has been conducted in the evaluation of the TI which is the segment&#xD;
      analyzable by both techniques. For the patients, demonstrate that the capsule is usable to&#xD;
      evaluate the mucosal healing, would be a considerable benefit knowing that the capsule do not&#xD;
      necessitate an arduous bowel cleansing and a sedation or a general anesthesia.&#xD;
&#xD;
      The proposed study is designed as a pilot study to evaluate the role of capsule endoscopy in&#xD;
      Crohn's disease patients, in monitoring the changes in the terminal ileum and small bowel&#xD;
      mucosa during Crohn's disease treatment for induction of remission in active Crohn's disease&#xD;
      with ileal involvement. Success in this trial may lead to a larger trial to validate the&#xD;
      findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment.</measure>
    <time_frame>week 0 and after 6 at 12 months</time_frame>
    <description>PGA will be evaluated based on capsule or Ileocolonoscopy procedures at week 0 and after 6 at 12 months in two ways as follows:&#xD;
Quantitative PGA assessment: the severity of the disease will be graded on an analogue visual scaled from 0 (no lesions identified) to 10 (lesions of maximum severity identified).&#xD;
Qualitative PGA assessment: the severity of the disease at weeks 0 and 40 will be classified into one of the following categories:&#xD;
No active disease&#xD;
Mild disease&#xD;
Moderate disease&#xD;
Severe disease&#xD;
Physician global assessment of the disease severity variation will be classified into:&#xD;
Definite Improvement&#xD;
Slightly improvement&#xD;
No change&#xD;
Slightly worsening&#xD;
Definite Worsening&#xD;
Disease severity variation will be also quantified by the change in quantitative PGA.&#xD;
The disease global severity will be later estimated by the two independent local investigators based on the previously capsule small bowel PGA and on the colonoscopy previously colon PGA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lewis score</measure>
    <time_frame>week 0 and after 6 at 12 months</time_frame>
    <description>The local readers will categorize lesions identified in RAPID. The Lewis score will be calculated later using a dedicated feature in the Rapid software, where the outcome is a continuous scale variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Segmental ileal and global CDEIS score</measure>
    <time_frame>week 0 and after 6 at 12 months</time_frame>
    <description>Segmental ileal and global CDEIS score will be evaluated later in continuance way based on ileo-colonoscopy and capsule findings at weeks 0 and after 6 at 12 months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Endoscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>CHANCE is a single arm study: all patients will undergo one capsule endoscopy ( PillCam® COLON 2 capsule and PillCam Crohn's) of the whole intestine AND one ileocolonoscopy.&#xD;
The patients will be then treated according to the preference of their physician and a second capsule endoscopy AND an ileoconoscopy will be performed 6 at 12 months later.&#xD;
Both exams will be evaluated locally by two independent investigators and all the recorded films will be evaluated and compared by four central readers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PillCam® COLON 2 and PillCam Crohn's capsules</intervention_name>
    <description>Patient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure:&#xD;
Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion.&#xD;
Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator.</description>
    <arm_group_label>Endoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject aged more than 18 years&#xD;
&#xD;
          -  Subject with at least ileal lesions of Crohn's disease&#xD;
&#xD;
          -  Subject with moderate to severe Crohn's disease at baseline, as defined by CDAI &gt; 150,&#xD;
&#xD;
          -  Subject accepting to undergo two capsules endoscopy and Ileocolonoscopy procedures&#xD;
&#xD;
          -  Proven patency by Agile capsule or another approach deemed clinically acceptable by&#xD;
             the investigator, e.g. CT enterography or MRI enterography, performed within the 6&#xD;
             months prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known gastrointestinal obstruction or strictures based on the clinical picture or pre&#xD;
             procedure testing and profile&#xD;
&#xD;
          -  Cardiac pacemakers or other implanted electromedical devices&#xD;
&#xD;
          -  Swallowing disorders.&#xD;
&#xD;
          -  Subject with known slow gastric emptying&#xD;
&#xD;
          -  Contraindications to ileocolonoscopy or general anasthesia&#xD;
&#xD;
          -  Subject with any condition, which precludes compliance with study and/or device&#xD;
             instructions&#xD;
&#xD;
          -  Women who are either pregnant or nursing at the time of screening, who intend to be&#xD;
             during the study period, or are of child-bearing potential and do not practice&#xD;
             medically acceptable methods of contraception.&#xD;
&#xD;
          -  Subject suffers from life threatening conditions&#xD;
&#xD;
          -  Subject currently participating in another clinical study&#xD;
&#xD;
          -  Subject has taken NSAID medications less than one month before enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Arnaud Bourreille, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU CAEN</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92 110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Kremlin Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Brabois</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Archet 2</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital St Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.getaid.org</url>
    <description>sponsor link</description>
  </link>
  <reference>
    <citation>Sands B.E. Crohn's Disease. Sleisenger and Fortran's Gastrointestinal and Liver Disease. 8th edition; Volume 2; Saunders Elsevier Publisher; Canada. 2006. pps 2459-2498.</citation>
  </reference>
  <reference>
    <citation>Lichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.</citation>
  </reference>
  <reference>
    <citation>Kornbluth A, Colombel JF, Leighton JA, Loftus E; ICCE. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005 Oct;37(10):1051-4. doi: 10.1055/s-2005-870315. No abstract available.</citation>
    <PMID>16189789</PMID>
  </reference>
  <reference>
    <citation>Engstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.</citation>
  </reference>
  <reference>
    <citation>Sipponen T, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Farkkila M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008 Jan;14(1):40-6. doi: 10.1002/ibd.20312.</citation>
    <PMID>18022866</PMID>
  </reference>
  <reference>
    <citation>Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. doi: 10.1046/j.1365-2036.17.s2.17.x.</citation>
    <PMID>12786607</PMID>
  </reference>
  <reference>
    <citation>Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005 Oct;37(10):960-5. doi: 10.1055/s-2005-870353. Erratum In: Endoscopy. 2007 Mar;39(4):303.</citation>
    <PMID>16189768</PMID>
  </reference>
  <reference>
    <citation>Mow WS, Lo SK, Targan SR, Dubinsky MC, Treyzon L, Abreu-Martin MT, Papadakis KA, Vasiliauskas EA. Initial experience with wireless capsule enteroscopy in the diagnosis and management of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2004 Jan;2(1):31-40. doi: 10.1016/s1542-3565(03)00289-1.</citation>
    <PMID>15017630</PMID>
  </reference>
  <reference>
    <citation>Dray X, Vahedi K, Valleur P, Marteau P. Is there any need for video capsule endoscopy evaluation in postduodenal small-bowel polyps detection in familial adenomatous polyposis? Gastrointest Endosc. 2007 Sep;66(3):634; author reply 634-5. doi: 10.1016/j.gie.2007.04.008. No abstract available.</citation>
    <PMID>17725961</PMID>
  </reference>
  <reference>
    <citation>Dionisio PM, Gurudu SR, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010 Jun;105(6):1240-8; quiz 1249. doi: 10.1038/ajg.2009.713. Epub 2009 Dec 22.</citation>
    <PMID>20029412</PMID>
  </reference>
  <reference>
    <citation>van Assche G, Vermeire S, Rutgeerts P. Mucosal healing and anti TNFs in IBD. Curr Drug Targets. 2010 Feb;11(2):227-33. doi: 10.2174/138945010790309902.</citation>
    <PMID>20210770</PMID>
  </reference>
  <reference>
    <citation>D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34. doi: 10.1016/s0016-5085(99)70005-3.</citation>
    <PMID>10220494</PMID>
  </reference>
  <reference>
    <citation>Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.</citation>
    <PMID>12047962</PMID>
  </reference>
  <reference>
    <citation>Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.</citation>
    <PMID>20393175</PMID>
  </reference>
  <reference>
    <citation>Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464. doi: 10.1016/j.gie.2005.08.011.</citation>
    <PMID>16500392</PMID>
  </reference>
  <reference>
    <citation>Dubcenco E, Jeejeebhoy KN, Petroniene R, Tang SJ, Zalev AH, Gardiner GW, Baker JP. Capsule endoscopy findings in patients with established and suspected small-bowel Crohn's disease: correlation with radiologic, endoscopic, and histologic findings. Gastrointest Endosc. 2005 Oct;62(4):538-44. doi: 10.1016/j.gie.2005.06.026.</citation>
    <PMID>16185968</PMID>
  </reference>
  <reference>
    <citation>Postgate AJ, Burling D, Gupta A, Fitzpatrick A, Fraser C. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci. 2008 Oct;53(10):2732-8. doi: 10.1007/s10620-008-0210-5. Epub 2008 Mar 5.</citation>
    <PMID>18320313</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>small bowel (SB)</keyword>
  <keyword>capsule endoscopy</keyword>
  <keyword>ileocolonoscopy</keyword>
  <keyword>anti-TNF-alpha antibodies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193802
org study id: GETAID 2012-3
secondary id: 2013-A00034-41
nct id: NCT02193802
lead sponsor: 
has dmc: No
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been
      demonstrated in a number of studies.

      Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of
      small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not
      complete since it does not allow exploration of the small bowel beyond the terminal ileum
      (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.
Crohn's disease is a chronic, inflammatory disorder affecting any part of the
      gastrointestinal tract but the terminal ileum is the most frequent location involved alone or
      in combination with other locations. While about one half of patients have involvement of the
      ileum and large bowel, another third have disease limited to the small bowel.

      The disease affects populations around the globe and occurs at any age but tends to have a
      peak incidence between the ages of 15 and 35. Typical presenting symptoms include abdominal
      pain and diarrhea. The clinical presentation of Crohn's disease fluctuates throughout the
      course of the disease. Symptoms and signs usually correlate with mucosal inflammation. The
      pattern of Crohn's disease viewed on endoscopy has been characterized and is associated with
      a number of mucosal characteristics such as erythema, swelling, nodularity, strictures,
      aphthoid ulceration and ulcers of variable size and depth.

      The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been
      demonstrated in a number of studies. Diagnostic yields of 70% have been reported in suspected
      SB Crohn's disease. In patients with a known Crohn's disease, the superiority of the capsule
      to detect mucosal lesions of the SB in comparison to any other radiologic technique has also
      been clearly demonstrated.

      A number of studies indicate that mucosal healing is a good predictor of long term remission.
      In particular, intense therapeutic regimens including purine analogues and biologic therapies
      like infliximab have been associated with endoscopic mucosal healing. The recently published
      SONIC trial evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy and
      the two drugs combined in moderate to severe Crohn's disease patients. Patients who were
      treated with infliximab monotherapy and with the combination therapy had significantly longer
      corticosteroid-free clinical remission than those receiving azathioprine alone. Furthermore,
      mucosal healing, defined as the absence of mucosal ulcerations at week 26, was greater for
      the combination therapy than each of the monotherapies alone. Based on the results of these
      studies, obtaining a mucosal healing becomes in clinical practice a new therapeutic objective
      especially in patients treated by immunosuppressors or anti-TNF-alpha antibodies. In most of
      the studies, a complete mucosal healing was assessed by the complete disappearance of
      ulceration. An endoscopic response could be evaluated by the variation of several endoscopic
      scores of severity, that are either dedicated to the terminal ileon (TI) more the colon i.e.
      the Crohn's disease endoscopic severity index (CDEIS) or to the SB i.e. the Lewis score.
      Concerning the evaluation of the mucosal lesions of the SB by the capsule, a new index of
      severity is being developed in a study conducted by the different centers of the GETAID i.e.
      the CE-CDEIS. This score will be available in the first semester of 2013 and would be usable
      for the present study.

      Unfortunately, the assessment of mucosal healing by conventional ileocolonoscopy is not
      complete since it does not allow exploration of the small bowel beyond TI. Thus, while
      mucosal changes and symptomatic improvement in subjects with SB Crohn's disease (with or
      without colonic involvement) can be inferred from studies like ACCENT I, direct evidence of
      the healing of the majority of the small bowel is lacking. In addition, correlation between
      evidence of mucosal healing and symptoms, as measured by the Crohn's Disease Activity Index
      (CDAI), has not been found reliable. This may reflect the limitation of viewing the full
      extent of small bowel ulcerations on the limited examination which is possible with
      ileocolonoscopy. This may potentially be overcome with the use of capsule endoscopy of the
      small bowel.

      Until now, no study has evaluated the potential treatment-induced changes of the mucosal
      lesions located in the SB with a capsule and no comparison between the capsule and the
      ileocolonoscopy has been conducted in the evaluation of the TI which is the segment
      analyzable by both techniques. For the patients, demonstrate that the capsule is usable to
      evaluate the mucosal healing, would be a considerable benefit knowing that the capsule do not
      necessitate an arduous bowel cleansing and a sedation or a general anesthesia.

      The proposed study is designed as a pilot study to evaluate the role of capsule endoscopy in
      Crohn's disease patients, in monitoring the changes in the terminal ileum and small bowel
      mucosa during Crohn's disease treatment for induction of remission in active Crohn's disease
      with ileal involvement. Success in this trial may lead to a larger trial to validate the
      findings.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment.
time frame: week 0 and after 6 at 12 months
description: PGA will be evaluated based on capsule or Ileocolonoscopy procedures at week 0 and after 6 at 12 months in two ways as follows:
Quantitative PGA assessment: the severity of the disease will be graded on an analogue visual scaled from 0 (no lesions identified) to 10 (lesions of maximum severity identified).
Qualitative PGA assessment: the severity of the disease at weeks 0 and 40 will be classified into one of the following categories:
No active disease
Mild disease
Moderate disease
Severe disease
Physician global assessment of the disease severity variation will be classified into:
Definite Improvement
Slightly improvement
No change
Slightly worsening
Definite Worsening
Disease severity variation will be also quantified by the change in quantitative PGA.
The disease global severity will be later estimated by the two independent local investigators based on the previously capsule small bowel PGA and on the colonoscopy previously colon PGA.
measure: Lewis score
time frame: week 0 and after 6 at 12 months
description: The local readers will categorize lesions identified in RAPID. The Lewis score will be calculated later using a dedicated feature in the Rapid software, where the outcome is a continuous scale variable.
measure: Segmental ileal and global CDEIS score
time frame: week 0 and after 6 at 12 months
description: Segmental ileal and global CDEIS score will be evaluated later in continuance way based on ileo-colonoscopy and capsule findings at weeks 0 and after 6 at 12 months.
arm group label: Endoscopy
arm group type: Other
description: CHANCE is a single arm study: all patients will undergo one capsule endoscopy ( PillCam® COLON 2 capsule and PillCam Crohn's) of the whole intestine AND one ileocolonoscopy.
The patients will be then treated according to the preference of their physician and a second capsule endoscopy AND an ileoconoscopy will be performed 6 at 12 months later.
Both exams will be evaluated locally by two independent investigators and all the recorded films will be evaluated and compared by four central readers.
intervention type: Device
intervention name: PillCam® COLON 2 and PillCam Crohn's capsules
description: Patient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure:
Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion.
Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator.
arm group label: Endoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Arnaud Bourreille, MD
role: Principal Investigator
affiliation: CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1
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country: France
country: Spain
url: http://www.getaid.org
description: sponsor link
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responsible party type: Sponsor
mesh term: Crohn Disease