Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter

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Brief Title

Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter

Official Title

Biliary Tissue Sampling Using a Cytology Brush or the G.I.U.M. Catheter: a Prospective Randomized Controlled Study.

Brief Summary

      Introduction In patients with a biliary obstruction, tissue is acquired immediately before
      drainage during endoscopic retrograde cholangio-pancreatography (ERCP). This is performed by
      passing a brush inside the bile duct stricture. However, brush cytology has a modest
      sensitivity (30-57%) for the diagnosis of cancer. A device, called the "G.I.U.M." catheter,
      allows for the sampling of higher amounts of tissue during ERCP compared to brush cytology.
      The aim of this study is to compare the diagnostic yield of tissue sampling performed in
      patients with a suspected malignant biliary stricture using 2 techniques, namely a standard
      brush catheter and the G.I.U.M..

      Protocol design Eligible patients will have tissue sampling performed using both techniques
      during ERCP, the first technique used being randomly assigned and immediately followed by the
      other one as well as biliary decompression. All specimens obtained will be subjected to
      cytopathological examination. After inclusion of the total number of patients, smears will be
      anonymized and analyzed for diagnosis, cell cellularity and quality. The final clinical
      diagnosis in each case will be based on cytologic results plus histological examination of
      biopsy specimens.
    

Detailed Description

      Introduction

      Many patients with a suspected malignant biliary obstruction are considered unsuitable for
      surgery because of locally advanced or metastatic disease or poor clinical performance
      status. Management of these patients is facilitated by a tissue diagnosis at initial
      endoscopic retrograde cholangio-pancreatography (ERCP). This may obviate further invasive
      tests, and the most suitable nonsurgical treatment can be initiated without delay. Brush
      cytology is the most frequently used technique. The procedure is relatively easy to perform,
      requires little time, and generally is safe. Although its specificity is close to 100%, brush
      cytology has a modest sensitivity that ranges from 30% to 57% in most published studies .

      A device, called the "G.I.U.M." catheter has been developed to increase the amount of tissue
      available for analysis 1. It consists of a basket with multiple wires that can be passed
      through the stricture, and grasp tissue between the wires. It has been shown in an
      uncontrolled study to allow for the diagnosis of malignancy with a high sensitivity
      (Endoscopy, submitted for publication).

      The aim of this study is to compare the diagnostic yield of tissue sampling performed using a
      standard brush catheter and the G.I.U.M. in patients with a suspected malignant biliary
      stricture.

      Selection of patients

      Inclusion criteria:

        -  Suspicion of malignant biliary stricture without prior histopathologic confirmation;

        -  Informed consent for ERCP, including sampling and dilation modalities, obtained.

      Exclusion criteria:

        -  Coagulopathy not corrected by administration of vitamin K or fresh frozen plasma;

        -  Inability to pass a guidewire through the stricture;

        -  Hilar stricture.

      Protocol design and management policy Eligible patients will have tissue sampling performed
      using both techniques, the first technique used being randomly assigned and immediately
      followed by the other one. Randomization will be performed by opening an opaque sealed
      envelope numbered according to a table of random numbers with blocks of 6 patients; each
      center will receive a pack of 24 numbered envelopes (made by an investigation nurse). A
      listing of all patients with a biliary stricture diagnosed at ERCP will be maintained (name,
      surname, date of birth, and date of examination), and reason for non inclusion will be
      stated.

      Methods of tissue sampling Antibiotics will be administered intravenously 30 minutes before
      ERCP. ERCP with biliary decompression will be performed with standard techniques. 2 After
      bile duct cannulation, iopromide (Ultravist, 300mgI/mL, Berlex, Montville, N.J.) will be
      injected, and the level and length of the biliary stricture will be determined. A guidewire
      will be passed through the stricture and intrahepatic opacification will be completed. A
      biliary sphincterotomy will be performed using a standard sphincterotome, to facilitate
      placement of a stent or of a naso-biliary drain. Pancreatography will possibly be attempted,
      especially if pancreatic disease is suspected.

      Tissue sampling will be performed in the order assigned by randomization, according to the
      following technique:

        -  Brush: the RX-cytology brush (M00545000, Boston Scientific Corp., Natick, Mass.) will be
           passed as a unit within its 8 French sheath, over the guidewire through the stricture.
           Previous stricture dilation will be left at the discretion of the endoscopist. The
           brush/sheath will be withdrawn immediately below the stricture, the brush will be moved
           forth and back within the strictured segment at least 10 times. The brush will then be
           pulled into the catheter, still located immediately below the stricture, and the unit
           brush/catheter will be removed. A X-ray will be taken with the top of the brush inside
           the stricture, and the X-ray will be kept in a dedicated file, as well as a X-ray with
           the stricture opacified with contrast medium. Specimens obtained with the brush will be
           smeared on glass slides and fixed in 95% ethanol immediately after collection, in the
           ERCP suite. Immediately after, the brush will be agitated in 10 ml of saline placed in a
           vial. Finally, the brush segment will be cut from the supportive wire and placed into a
           container with CytoLytt solution (Cytyc, Crawley, United Kingdom).

        -  G.I.U.M.: immediately before using the G.I.U.M. catheter, the biliary stricture will be
           dilated using a 6-mm in diameter MaxForce balloon catheter (Microvasive Endoscopy,
           Boston Sc.). The G.I.U.M. catheter will be passed as a unit within its 8.5F sheath,
           alongside the guidewire. Once the basket/sheath is located above the stricture, the
           basket will be opened and passed through the strictured segment 1 time. The basket will
           then be pulled into the catheter, and the unit basket/catheter will be removed.. A X-ray
           will be taken with the meshes of the G.I.U.M. catheter opened inside the stricture, and
           the X-ray will be kept in a dedicated file. Specimens obtained with the G.I.U.M. will be
           smeared on glass slides and fixed in 95% ethanol immediately after collection, in the
           ERCP suite. Immediately after, the G.I.U.M. will be agitated in 10 ml of saline placed
           in a vial. Finally, all the material remaining between the wires of the G.I.U.M. will be
           rinsed through the sheath into a vial by perfusing 30 ml of CytoLytt solution (Cytyc)
           taken from the vial furnished by the manufacturer using a 20-ml sterile syringe into the
           same vial.

      Smears as well as the 2 vials of saline and the 2 vials of CytoLytt will be labeled with the
      patient's name and the mark "G.I.U.M." or "brush".

      Complications possibly detected during ERCP or during the 30 following days will be noted and
      assessed by using established consensus criteria. 3

      Preparation of tissue sample Cytolytt vials: specimens in Cytolytt will be prepared according
      to the ThinPrep processor operator manual (http://www.thinprep.com/85506Prd/gencyt.htm).
      Specimens obtained with the ThinPrep technique will be processed for 1 slide as described by
      the manufacturer. Cell block inclusion will be performed whenever possible.

      Smears: specimens will be stained by the Papanicolaou technique for standard cytologic
      examination.

      Cytopathological examination After inclusion of the total number of patients, labels and
      marks on the smears will be removed and replaced by random numbers. Two non-consecutive
      random numbers from 1 to 1000 will be selected for each patient, one for the smear obtained
      with the G.I.U.M., the other for the smear obtained with the brush by JMD. Smears will be
      re-read by two cytopathologists blinded to the name of the patient, the technique of tissue
      sampling, previous diagnosis, as well as the relationship between the 2 random numbers for
      each pair of samples collected from the same patient (so avoiding interpretation of a sample
      obtained using one of the 2 techniques with the knowledge of the sample obtained from the
      same patient using the other technique). Indeed, their knowledge will be limited to the fact
      that a biliary stricture was identified at ERCP. Final diagnosis will be reached by agreement
      between the 2 cytopathologists. Specimens will be interpreted as normal, atypical (considered
      benign), highly atypical (suspicious for cancer), and malignant. Cell cellularity and single
      epithelial cell cellularity will be graded as absent, rare, moderate, or numerous. Finally,
      nuclear detail will be graded as poor, satisfactory, or excellent. Other data will be
      recorded as indicated in Table 1.

      A list of patients' names for whom cell block inclusion has been performed will be kept, with
      indication if it was obtained from material collected with the cytobrush or with the G.I.U.M.

      Histopathological examination Surgical specimens obtained from patients who undergo
      duodenopancreatectomy will be subjected to histopathological examination, in particular to
      detect carcinomatous lymphangitis.

      Statistical analysis The final clinical diagnosis in each case will be based on cytologic
      results plus specimens obtained at surgery, autopsy, via percutaneous puncture or endoscopic
      ultrasonography with fine needle aspiration, and disease course, including signs of clinical
      deterioration, death, or a stable course and/or improvement during follow-up. Information
      will be collected by reviewing hospital records and telephone contact with patients/families
      and referring physicians 1, 6 and 12 months after ERCP.

      For the purpose of calculating sensitivity and specificity, all highly atypical (suspicious
      for cancer) and malignant diagnoses at cytopathologic examination will be regarded as
      "positive", and diagnoses of normal and atypical (considered benign) will be regarded as
      "negative".4 Sensitivity and specificity will be calculated using the Fischer exact test. A p
      value less than 0.05 will be considered statistically significant.

      Based on the hypothesis that the sensitivity for the detection of cancer would be 45 4 and
      70% on specimens obtained with the brush and the G.I.U.M. catheter respectively, we calculate
      that at least 68 patients with a final clinical diagnosis of cancer should be included to
      reach statistical significance with 5% and 20% alpha and beta error, respectively.

      An interim analysis will be performed after collection of resection specimens in 5 patients
      to evaluate possible lesions to the biliary tract and surrounding tissues.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Sensitivity and specificity for the diagnosis of malignancy with both devices

Secondary Outcome

 30-day complication rate.

Condition

Pancreatic Neoplasms

Intervention

Tissue sampling ("G.I.U.M." catheter)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

68

Start Date

October 2004



Eligibility Criteria

        Inclusion Criteria:

          -  Suspicion of malignant biliary stricture without prior histopathologic confirmation;

          -  Informed consent for ERCP, including sampling and dilation modalities, obtained.

        Exclusion Criteria:

          -  Coagulopathy not corrected by administration of vitamin K or fresh frozen plasma;

          -  Inability to pass a guidewire through the stricture;

          -  Hilar stricture
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean-Marc Dumonceau, MD,PhD, +41223729340, [email protected]

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT00160836

Organization ID

CER 04-117



Study Sponsor

University Hospital, Geneva


Study Sponsor

Jean-Marc Dumonceau, MD,PhD, Study Chair, University Hospital, Geneva


Verification Date

April 2007