<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/NCT02188316</url>
  </required_header>
  <id_info>
    <org_study_id>HNEAH-KAEK 2014/22</org_study_id>
    <nct_id>NCT02188316</nct_id>
  </id_info>
  <brief_title>Comparison of Jumbo and Hot Biopsy Forceps</brief_title>
  <official_title>The Histological Quality and Adequacy of Diminutive Colorectal Polyps Resected Using Jumbo Versus Hot Biopsy Forceps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Camlıca Erdem Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Camlıca Erdem Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Cold forceps polypectomy and hot biopsy forceps electrocauterization (HBF) are still&#xD;
           widely used methods for endoscopic resection of diminutive colorectal polyps&#xD;
           (DCPs)(polyps smaller than 5 mm). Jumbo forceps may be more effective in the removal of&#xD;
           DCPs because of their larger size.&#xD;
&#xD;
        -  This was a prospective study of consecutive patients undergoing colonoscopy and found to&#xD;
           have at least one diminutive polyp. One experienced endoscopist removed DCPs using&#xD;
           either jumbo or hot biopsy forceps.&#xD;
&#xD;
        -  Aim was to evaluate the histological quality and adequacy of the DCPs resected using&#xD;
           jumbo forceps in comparison with HBF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Exclusion criteria were (i) having abnormal coagulation parameters and thrombocytopenia,&#xD;
           taking aspirin or other medications which could affect bleeding time, (ii) history of&#xD;
           inflammatory bowel disease, (iii) pregnancy.&#xD;
&#xD;
        -  One experienced endoscopist carried out all the procedures using the same techniques.&#xD;
&#xD;
        -  If a diminutive polyp was detected during colonoscopy, and it was estimated that the&#xD;
           polyp was eligible for the study, the patient was randomly assigned by the physician to&#xD;
           one of the two forceps groups (hot biopsy versus jumbo forceps) using a flipping coin&#xD;
           method. Polypectomy was then performed with the intention to remove all polypoid tissue&#xD;
           with one forceps bite. After the initial bite was obtained, the polypectomy site was&#xD;
           observed with visual inspection. If residual polypoid tissue was observed after the&#xD;
           first bite, additional biopsies were taken until visual eradication was attained.&#xD;
&#xD;
        -  The size of the polyp was estimated during colonoscopy by visual comparison with the&#xD;
           open biopsy forceps (Open-biopsy forceps technique). Polypectomies were performed using&#xD;
           jumbo forceps (Conmed, USA) and hot biopsy forceps (Wilson-Cook Medical, USA). For HBF,&#xD;
           the technique was based on the procedure first described in 1973, as follows: slight&#xD;
           pulling force was applied to the polyp and then the electrocautery current was applied&#xD;
           until the white coagulum was seen at the polyp base. The technique for jumbo forceps was&#xD;
           as follows: after initial grasping, slight force was applied until the polyp was&#xD;
           separated from the stalk. The electrocautery current waveform and intensity settings&#xD;
           were the same for each patient. Each biopsy specimen was placed in a separate formalin&#xD;
           solution.&#xD;
&#xD;
        -  An experienced blinded pathologist evaluated the tissue samples for depth of specimen,&#xD;
           amount of cautery damage (for hot biopsy forceps) or crush artifacts (for jumbo&#xD;
           forceps), architecture, fragmentation, overall diagnostic quality, evaluation and&#xD;
           positivity of surgical margins.&#xD;
&#xD;
        -  All statistical analyses were performed using SPSS for Windows v. 15 (SPSS Inc.,&#xD;
           Chicago, IL, USA). Demographic, biochemical and histopathological features were&#xD;
           classified as continuous or categorical variables. Kolmogorov-Smirnov analysis was used&#xD;
           to test for Gaussian distribution. The data were expressed as arithmetic mean ± standard&#xD;
           deviation (SD), since the evaluated variables were Gaussian-distributed. Comparisons&#xD;
           between two groups were performed using the Student's t-test for continuous variables.&#xD;
           Categorical variables were compared using the χ2 test (2X2, 3X2 and 4X2 tables) and&#xD;
           Fisher's exact test. When the chi-square test was used, Yates' correction for continuity&#xD;
           was used. All reported p-values were two-tailed, and those less than 0.05 were&#xD;
           considered to be statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete eradication of diminutive polyps.</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adequate histopathological diagnosis</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Colonoscopy</condition>
  <condition>Polypectomy</condition>
  <arm_group>
    <arm_group_label>Jumbo forceps polypectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>89 patients were randomized to jumbo forceps arm and 120 diminutive colorectal polyps were removed by jumbo forceps polypectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hot biopsy electrocauterization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>90 patients were randomized to hot biopsy forceps arm and 117 diminutive colorectal polyps were removed by hot biopsy electrocauterization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Jumbo forceps</intervention_name>
    <description>comparison of different polypectomy devices</description>
    <arm_group_label>Jumbo forceps polypectomy</arm_group_label>
    <other_name>Jumbo forceps (Conmed, USA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hot biopsy forceps</intervention_name>
    <description>comparison of different polypectomy devices</description>
    <arm_group_label>Hot biopsy electrocauterization</arm_group_label>
    <other_name>Hot biopsy forceps (Wilson-Cook Medical, USA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients found to have at least one diminutive polyp (measuring ≤ 5 mm).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having abnormal coagulation parameters and thrombocytopenia&#xD;
&#xD;
          -  Taking aspirin or other medications which could affect bleeding time&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Camlıca Erdem Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34660</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Camlıca Erdem Hospital</investigator_affiliation>
    <investigator_full_name>Bulent Yasar</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Cold forceps polypectomy</keyword>
  <keyword>Diminutive colorectal polyp</keyword>
  <keyword>Hot biopsy forceps electrocauterization</keyword>
  <keyword>Jumbo forceps.</keyword>
  <!-- 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/NCT02188316
org study id: HNEAH-KAEK 2014/22
nct id: NCT02188316
lead sponsor: 
has dmc: Yes
-  Cold forceps polypectomy and hot biopsy forceps electrocauterization (HBF) are still
           widely used methods for endoscopic resection of diminutive colorectal polyps
           (DCPs)(polyps smaller than 5 mm). Jumbo forceps may be more effective in the removal of
           DCPs because of their larger size.

        -  This was a prospective study of consecutive patients undergoing colonoscopy and found to
           have at least one diminutive polyp. One experienced endoscopist removed DCPs using
           either jumbo or hot biopsy forceps.

        -  Aim was to evaluate the histological quality and adequacy of the DCPs resected using
           jumbo forceps in comparison with HBF.
-  Exclusion criteria were (i) having abnormal coagulation parameters and thrombocytopenia,
           taking aspirin or other medications which could affect bleeding time, (ii) history of
           inflammatory bowel disease, (iii) pregnancy.

        -  One experienced endoscopist carried out all the procedures using the same techniques.

        -  If a diminutive polyp was detected during colonoscopy, and it was estimated that the
           polyp was eligible for the study, the patient was randomly assigned by the physician to
           one of the two forceps groups (hot biopsy versus jumbo forceps) using a flipping coin
           method. Polypectomy was then performed with the intention to remove all polypoid tissue
           with one forceps bite. After the initial bite was obtained, the polypectomy site was
           observed with visual inspection. If residual polypoid tissue was observed after the
           first bite, additional biopsies were taken until visual eradication was attained.

        -  The size of the polyp was estimated during colonoscopy by visual comparison with the
           open biopsy forceps (Open-biopsy forceps technique). Polypectomies were performed using
           jumbo forceps (Conmed, USA) and hot biopsy forceps (Wilson-Cook Medical, USA). For HBF,
           the technique was based on the procedure first described in 1973, as follows: slight
           pulling force was applied to the polyp and then the electrocautery current was applied
           until the white coagulum was seen at the polyp base. The technique for jumbo forceps was
           as follows: after initial grasping, slight force was applied until the polyp was
           separated from the stalk. The electrocautery current waveform and intensity settings
           were the same for each patient. Each biopsy specimen was placed in a separate formalin
           solution.

        -  An experienced blinded pathologist evaluated the tissue samples for depth of specimen,
           amount of cautery damage (for hot biopsy forceps) or crush artifacts (for jumbo
           forceps), architecture, fragmentation, overall diagnostic quality, evaluation and
           positivity of surgical margins.

        -  All statistical analyses were performed using SPSS for Windows v. 15 (SPSS Inc.,
           Chicago, IL, USA). Demographic, biochemical and histopathological features were
           classified as continuous or categorical variables. Kolmogorov-Smirnov analysis was used
           to test for Gaussian distribution. The data were expressed as arithmetic mean ± standard
           deviation (SD), since the evaluated variables were Gaussian-distributed. Comparisons
           between two groups were performed using the Student's t-test for continuous variables.
           Categorical variables were compared using the χ2 test (2X2, 3X2 and 4X2 tables) and
           Fisher's exact test. When the chi-square test was used, Yates' correction for continuity
           was used. All reported p-values were two-tailed, and those less than 0.05 were
           considered to be statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Complete eradication of diminutive polyps.
time frame: 3 months
measure: Adequate histopathological diagnosis
time frame: 3 months
arm group label: Jumbo forceps polypectomy
arm group type: Active Comparator
description: 89 patients were randomized to jumbo forceps arm and 120 diminutive colorectal polyps were removed by jumbo forceps polypectomy.
arm group label: Hot biopsy electrocauterization
arm group type: Active Comparator
description: 90 patients were randomized to hot biopsy forceps arm and 117 diminutive colorectal polyps were removed by hot biopsy electrocauterization.
intervention type: Device
intervention name: Jumbo forceps
description: comparison of different polypectomy devices
arm group label: Jumbo forceps polypectomy
other name: Jumbo forceps (Conmed, USA)
intervention type: Device
intervention name: Hot biopsy forceps
description: comparison of different polypectomy devices
arm group label: Hot biopsy electrocauterization
other name: Hot biopsy forceps (Wilson-Cook Medical, USA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Camlıca Erdem Hospital
investigator full name: Bulent Yasar
investigator title: MD