xml: <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/NCT06031740</url>
    </required_header>
    <id_info>
      <org_study_id>ILBS-Cirrhosis-63</org_study_id>
      <nct_id>NCT06031740</nct_id>
    </id_info>
    <brief_title>A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids</brief_title>
    <official_title>A Randomized Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Liver and Biliary Sciences, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Liver and Biliary Sciences, India</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Haemorrhoids are the most common proctologic disease, affecting up to 36% of people in the&#xD;
        developed world. Sclerotherapy is deﬁned as the injection of sclerosing agents at the apex of&#xD;
        the internal hemorrhoidal complex, above the dentate line, leading to scarring, ﬁbrosis, and&#xD;
        ﬁxation of the hemorrhoids. Sclerotherapy as a treatment of internal hemorrhoids has been&#xD;
        used for a long time by surgeons, using proctoscopic exposure. Even though flexible&#xD;
        instruments can be expected to have better manoeuvrability and target site exposure. There is&#xD;
        no consensus amongst the major guidelines as to which grade of haemorrhoid that sclerotherapy&#xD;
        should be used, whether it is equivalent or inferior to rubber bad ligation (RBL), whether&#xD;
        sclerotherapy should be used at all for the treatment of IH, what is the effect of PHT on&#xD;
        hemorrhoid prevalence and propensity to bleed, differentiation of internal hemorrhoids from&#xD;
        rectal varices, data on EBL or EST in cirrhotics with hemorrhoids, safety of endotherapy with&#xD;
        underlying coagulopathy and concerns for infectious complications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hypothesis :- Polidocanol foam sclerotherapy is more effective than liquid polidocanol&#xD;
        sclerotherapy, for bleeding cessation from internal hemorrhoids in cirrhotic patients.&#xD;
  &#xD;
        Aim and Objective - To compare flexible endoscopic polidocanol liquid and foam sclerotherapy&#xD;
        in cirrhotic patients with bleeding from internal hemorrhoids&#xD;
  &#xD;
        Primary objective: No recurrence of hemorrhoidal bleeding episodes at 1-week after&#xD;
        endotherapy&#xD;
  &#xD;
        Secondary objectives:&#xD;
  &#xD;
          1. Ano-rectal bleeding at 4-wks, defined by Giamundo score. [Ordinal score 0-4]&#xD;
  &#xD;
          2. Ano-rectal bleeding at 8-wks, defined by Giamundo score. [Ordinal score 0-4]&#xD;
  &#xD;
          3. Proportion of patients requiring a 2nd treatment session within 8-wks. [Indications:&#xD;
             Giamundo score &gt;3, or hemoglobin drop &gt;1g/dL, or requirement of transfusion, or&#xD;
             clinician discretion; Time frame: 8-weeks]&#xD;
  &#xD;
          4. Proportion of patients with failed endotherapy. [Persistent bleeding with Giamundo score&#xD;
             &gt;3 from internal hemorrhoids or treatment related ulcers, after 2nd endotherapy session;&#xD;
             Time frame: 8-weeks]&#xD;
  &#xD;
          5. Proportion of patients requiring BT for hemorrhoidal bleeding within 8 wks.&#xD;
  &#xD;
          6. Relationship of MELD score (4-40) with no recurrence of bleeding at 7d.&#xD;
  &#xD;
          7. Adverse events/ local infectious complications after endotherapy. [Time frame: 8-wks]&#xD;
  &#xD;
          8. Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal&#xD;
             varices and/or portal colopathy.&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
        - Study population: Patients with cirrhosis, attending outpatient clinics or admitted, with&#xD;
        ano-rectal bleeding suspicious to be hemorrhoidal in origin. Investigator will include both&#xD;
        compensated and decompensated (acute or chronic) cirrhotics with anorectal bleed, and&#xD;
        patients with ACLF with ano rect1al bleed.&#xD;
  &#xD;
        Study design: Open label, parallel group, randomized, controlled study.&#xD;
  &#xD;
          -  Study period: 1 year after IEC approval.&#xD;
  &#xD;
          -  Sample size with justification: Treatment success at 1-wk, after one liquid&#xD;
             sclerotherapy session is expected in 50% cirrhotics.Treatment success after one session&#xD;
             of foam sclerotherapy is expected in 85% cirrhotics. Assuming efficacy difference of&#xD;
             35%, significance (α) at 0.5, power of 80%, the two groups should include 27 patients&#xD;
             each (Total 54). To compensate for dropouts, final sample size of 60 patients.&#xD;
  &#xD;
          -  Intervention:&#xD;
  &#xD;
          -  Cap-assisted, flexible endoscopic treatment in both groups.&#xD;
  &#xD;
          -  Group 1: Sclerotherapy with 1.5% polidocanol. 2mL (3%) polidocanol = 60mg; maximal dose:&#xD;
             1mL/column and 4mL/session.&#xD;
  &#xD;
          -  Group 2: Foam sclerotherapy. Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal&#xD;
             dose: 2mL/column and 20mL/session.&#xD;
  &#xD;
          -  Monitoring and assessment:&#xD;
  &#xD;
          -  Time of index procedure will be considered as baseline (T0). There will be three&#xD;
             scheduled evaluation time points: At 1 week (T1), 4 weeks (T2), and at 8 weeks (T3).&#xD;
  &#xD;
          -  The degree of bleeding, prolapse, pain, quality of life, and patient satisfaction will&#xD;
             be recorded at each visit.&#xD;
  &#xD;
          -  Statistical Analysis: The results will be reported as counts and percentages for&#xD;
             categorical variables, and as mean ± SD (range) for continuous normally distributed&#xD;
             variables and median (interquartile range [IQR]) for ordinal categorical variables and&#xD;
             for continuous non-normally distributed variables. The chi-square test will be used for&#xD;
             cross-tabulations. Continuous variables will be compared between the groups by using the&#xD;
             Student's t test or the Mann-Whitney test, depending on the data distribution.The time&#xD;
             to recurrence will be evaluated as the time elapsed from treatment success to the&#xD;
             relapse of bleeding (at least 2 for the Giamundo bleeding score). Kaplan-Meier curves&#xD;
             will be used to evaluate freedom from recurrence; statistical comparison of survival&#xD;
             curves will be carried out by the log-rank test.The changes in the Giamundo score, and&#xD;
             HDSS scores over time will be analyzed with the Friedman test, because these scores are&#xD;
             not normally distributed. The results associated with a p-value &lt;0.05 will be considered&#xD;
             statistically significant.&#xD;
  &#xD;
          -  Adverse effects:&#xD;
  &#xD;
          -  The AEs will be classified as none, remote, possible, probable, or not assessable based&#xD;
             on the relation with the sclerosant.&#xD;
  &#xD;
          -  Specific AEs to report:-&#xD;
  &#xD;
               1. Bleeding requiring Blood Tx, with hemodynamic instability or need for urgent&#xD;
                  surgery&#xD;
  &#xD;
               2. External thrombosis requiring surgical intervention&#xD;
  &#xD;
               3. Occurrence of urinary retention&#xD;
  &#xD;
               4. Prostatic infection&#xD;
  &#xD;
               5. Sexual dysfunction in men&#xD;
  &#xD;
               6. Perineal abscess&#xD;
  &#xD;
               7. Sepsis&#xD;
  &#xD;
          -  Stopping rule of study:&#xD;
  &#xD;
          -  Study will be stopped in case of life-threatening adverse event judged to be related to&#xD;
             the protocol intervention at department review meeting.&#xD;
  &#xD;
             (c) Expected outcome of the project:&#xD;
  &#xD;
          -  Establishment of an effective treatment protocol for hemorrhoidal bleeding in cirrhotic&#xD;
             patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 7, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients with no recurrence of hemorrhoidal bleeding episodes at 1 week after endotherapy.</measure>
      <time_frame>1 week</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with ano-rectal bleeding at 4 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome</measure>
      <time_frame>4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with ano-rectal bleeding at 8 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients requiring a 2nd treatment session within 8 weeks</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with failed endotherapy.</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients requiring BT for hemorrhoidal bleeding within 8 weeks.</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship of Model for end stage liver disease (MELD) score with no recurrence of bleeding at 7 days [ Minimum 4 to maximum 40; Higher meaning worse.</measure>
      <time_frame>7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events/ local infectious complications after endotherapy.</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal varices and/or portal colopathy.</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Liver Cirrhosis</condition>
    <condition>Internal Hemorrhoid</condition>
    <arm_group>
      <arm_group_label>Sclerotherapy with 1.5% polidocanol.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2mL (3%) polidocanol = 60mg; maximal dose: 1mL/column and 4mL/session.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Foam sclerotherapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal dose: 2mL/column and 20mL/session.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Sclerotherapy with 1.5% polidocanol</intervention_name>
      <description>2mL (3%) polidocanol = 60mg; maximal dose: 1mL/column and 4mL/session.&#xD;
  - Group 2: Foam sclerotherapy.</description>
      <arm_group_label>Sclerotherapy with 1.5% polidocanol.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Foam sclerotherapy.</intervention_name>
      <description>Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal dose: 2mL/column and 20mL/session.</description>
      <arm_group_label>Foam sclerotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Cirrhotic/ACLF patients with ano-rectal bleeding, either ongoing or within last&#xD;
               1-week, judged to be hemorrhoidal in origin based on clinical features and endoscopy&#xD;
               evaluation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Coagulopathy threshold of INR &gt;2.0 and/or platelet count &lt;50,000/mm3.&#xD;
  &#xD;
            2. Antiplatelet or anticoagulants use.&#xD;
  &#xD;
            3. Immunosuppressive medications (including steroids &gt;20mg/d or equivalent for &gt;2 weeks).&#xD;
  &#xD;
            4. Grade IV internal hemorrhoids.&#xD;
  &#xD;
            5. Thrombosed or strangulated IH or EH.&#xD;
  &#xD;
            6. Previous EST or RBL in last 1-year.&#xD;
  &#xD;
            7. Co-existing ano-rectal diseases like perianal abscess, stricture, ﬁstula, anal&#xD;
               malignancies, ano-rectal stenosis, radiation proctitis, or proctitis.&#xD;
  &#xD;
            8. Patients not capable of understanding and signing the informed consent.&#xD;
  &#xD;
            9. Pregnancy.&#xD;
  &#xD;
           10. Bronchial Asthma.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr Srajit Singh, MD</last_name>
      <phone>01146300000</phone>
      <email>srajitsinghparmar@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institute of Liver &amp; Biliary Sciences (ILBS)</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110070</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Srajit Singh, MD</last_name>
        <phone>01146300000</phone>
        <email>srajitsinghparmar@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Cirrhosis</mesh_term>
      <mesh_term>Hemorrhoids</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polidocanol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031740
  org study id: ILBS-Cirrhosis-63
  nct id: NCT06031740
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Haemorrhoids are the most common proctologic disease, affecting up to 36% of people in the
        developed world. Sclerotherapy is deﬁned as the injection of sclerosing agents at the apex of
        the internal hemorrhoidal complex, above the dentate line, leading to scarring, ﬁbrosis, and
        ﬁxation of the hemorrhoids. Sclerotherapy as a treatment of internal hemorrhoids has been
        used for a long time by surgeons, using proctoscopic exposure. Even though flexible
        instruments can be expected to have better manoeuvrability and target site exposure. There is
        no consensus amongst the major guidelines as to which grade of haemorrhoid that sclerotherapy
        should be used, whether it is equivalent or inferior to rubber bad ligation (RBL), whether
        sclerotherapy should be used at all for the treatment of IH, what is the effect of PHT on
        hemorrhoid prevalence and propensity to bleed, differentiation of internal hemorrhoids from
        rectal varices, data on EBL or EST in cirrhotics with hemorrhoids, safety of endotherapy with
        underlying coagulopathy and concerns for infectious complications.
  Hypothesis :- Polidocanol foam sclerotherapy is more effective than liquid polidocanol
        sclerotherapy, for bleeding cessation from internal hemorrhoids in cirrhotic patients.
  
        Aim and Objective - To compare flexible endoscopic polidocanol liquid and foam sclerotherapy
        in cirrhotic patients with bleeding from internal hemorrhoids
  
        Primary objective: No recurrence of hemorrhoidal bleeding episodes at 1-week after
        endotherapy
  
        Secondary objectives:
  
          1. Ano-rectal bleeding at 4-wks, defined by Giamundo score. [Ordinal score 0-4]
  
          2. Ano-rectal bleeding at 8-wks, defined by Giamundo score. [Ordinal score 0-4]
  
          3. Proportion of patients requiring a 2nd treatment session within 8-wks. [Indications:
             Giamundo score >3, or hemoglobin drop >1g/dL, or requirement of transfusion, or
             clinician discretion; Time frame: 8-weeks]
  
          4. Proportion of patients with failed endotherapy. [Persistent bleeding with Giamundo score
             >3 from internal hemorrhoids or treatment related ulcers, after 2nd endotherapy session;
             Time frame: 8-weeks]
  
          5. Proportion of patients requiring BT for hemorrhoidal bleeding within 8 wks.
  
          6. Relationship of MELD score (4-40) with no recurrence of bleeding at 7d.
  
          7. Adverse events/ local infectious complications after endotherapy. [Time frame: 8-wks]
  
          8. Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal
             varices and/or portal colopathy.
  
        Methodology:
  
        - Study population: Patients with cirrhosis, attending outpatient clinics or admitted, with
        ano-rectal bleeding suspicious to be hemorrhoidal in origin. Investigator will include both
        compensated and decompensated (acute or chronic) cirrhotics with anorectal bleed, and
        patients with ACLF with ano rect1al bleed.
  
        Study design: Open label, parallel group, randomized, controlled study.
  
          -  Study period: 1 year after IEC approval.
  
          -  Sample size with justification: Treatment success at 1-wk, after one liquid
             sclerotherapy session is expected in 50% cirrhotics.Treatment success after one session
             of foam sclerotherapy is expected in 85% cirrhotics. Assuming efficacy difference of
             35%, significance (α) at 0.5, power of 80%, the two groups should include 27 patients
             each (Total 54). To compensate for dropouts, final sample size of 60 patients.
  
          -  Intervention:
  
          -  Cap-assisted, flexible endoscopic treatment in both groups.
  
          -  Group 1: Sclerotherapy with 1.5% polidocanol. 2mL (3%) polidocanol = 60mg; maximal dose:
             1mL/column and 4mL/session.
  
          -  Group 2: Foam sclerotherapy. Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal
             dose: 2mL/column and 20mL/session.
  
          -  Monitoring and assessment:
  
          -  Time of index procedure will be considered as baseline (T0). There will be three
             scheduled evaluation time points: At 1 week (T1), 4 weeks (T2), and at 8 weeks (T3).
  
          -  The degree of bleeding, prolapse, pain, quality of life, and patient satisfaction will
             be recorded at each visit.
  
          -  Statistical Analysis: The results will be reported as counts and percentages for
             categorical variables, and as mean ± SD (range) for continuous normally distributed
             variables and median (interquartile range [IQR]) for ordinal categorical variables and
             for continuous non-normally distributed variables. The chi-square test will be used for
             cross-tabulations. Continuous variables will be compared between the groups by using the
             Student's t test or the Mann-Whitney test, depending on the data distribution.The time
             to recurrence will be evaluated as the time elapsed from treatment success to the
             relapse of bleeding (at least 2 for the Giamundo bleeding score). Kaplan-Meier curves
             will be used to evaluate freedom from recurrence; statistical comparison of survival
             curves will be carried out by the log-rank test.The changes in the Giamundo score, and
             HDSS scores over time will be analyzed with the Friedman test, because these scores are
             not normally distributed. The results associated with a p-value <0.05 will be considered
             statistically significant.
  
          -  Adverse effects:
  
          -  The AEs will be classified as none, remote, possible, probable, or not assessable based
             on the relation with the sclerosant.
  
          -  Specific AEs to report:-
  
               1. Bleeding requiring Blood Tx, with hemodynamic instability or need for urgent
                  surgery
  
               2. External thrombosis requiring surgical intervention
  
               3. Occurrence of urinary retention
  
               4. Prostatic infection
  
               5. Sexual dysfunction in men
  
               6. Perineal abscess
  
               7. Sepsis
  
          -  Stopping rule of study:
  
          -  Study will be stopped in case of life-threatening adverse event judged to be related to
             the protocol intervention at department review meeting.
  
             (c) Expected outcome of the project:
  
          -  Establishment of an effective treatment protocol for hemorrhoidal bleeding in cirrhotic
             patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of patients with no recurrence of hemorrhoidal bleeding episodes at 1 week after endotherapy.
  time frame: 1 week
  measure: Number of participants with ano-rectal bleeding at 4 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome
  time frame: 4 weeks
  measure: Number of participants with ano-rectal bleeding at 8 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome
  time frame: 8 weeks
  measure: Proportion of patients requiring a 2nd treatment session within 8 weeks
  time frame: 8 weeks
  measure: Proportion of patients with failed endotherapy.
  time frame: 8 weeks
  measure: Proportion of patients requiring BT for hemorrhoidal bleeding within 8 weeks.
  time frame: 8 weeks
  measure: Relationship of Model for end stage liver disease (MELD) score with no recurrence of bleeding at 7 days [ Minimum 4 to maximum 40; Higher meaning worse.
  time frame: 7 days
  measure: Adverse events/ local infectious complications after endotherapy.
  time frame: 8 weeks
  measure: Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal varices and/or portal colopathy.
  time frame: 8 weeks
  arm group label: Sclerotherapy with 1.5% polidocanol.
  arm group type: Experimental
  description: 2mL (3%) polidocanol = 60mg; maximal dose: 1mL/column and 4mL/session.
  arm group label: Foam sclerotherapy
  arm group type: Active Comparator
  description: Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal dose: 2mL/column and 20mL/session.
  intervention type: Procedure
  intervention name: Sclerotherapy with 1.5% polidocanol
  description: 2mL (3%) polidocanol = 60mg; maximal dose: 1mL/column and 4mL/session.
  - Group 2: Foam sclerotherapy.
  arm group label: Sclerotherapy with 1.5% polidocanol.
  intervention type: Procedure
  intervention name: Foam sclerotherapy.
  description: Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal dose: 2mL/column and 20mL/session.
  arm group label: Foam sclerotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Dr Srajit Singh, MD
  phone: 01146300000
  email: srajitsinghparmar@gmail.com
  facility: 
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Liver Cirrhosis
  mesh term: Hemorrhoids
  mesh term: Polidocanol
  sharing ipd: No