To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleeding Rectal Varices, Among Patients With Portal Hypertension

October 11, 2021 updated by: Institute of Liver and Biliary Sciences, India

To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleeding Rectal Varices, Among Patients With Portal Hypertension.

Rectal varices (RVs) are an important cause of lower gastrointestinal bleed (LGIB) in portal hypertension (PHT) and have been reported to occur in 44% to 89% of cases of cirrhosis. RVs are dilated sub-mucosal porto-systemic communications which extend from mid rectum to the ano-rectal junction and are considered distinct from internal hemorrhoids, which are submucosal arterio-venous communications of the anorectal vascular plexus. The suspicion of RVs as the cause of bleeding can be made with a high index of suspicion when lower GI bleed is seen in absence of hemorrhoids, and colonoscopy shows blood in rectum. Bleeding usually happens from endoscopically evident rectal varices (EERV) but sometimes bleed can occur from varices, which are endoscopically in evident (EIERV). Endoscopic ultrasound (EUS) has been shown to be more sensitive in diagnosis of EIERV. Endoscopic and EUS correlation of RVs has shown that RVs, classified as tortuous, nodular, and tumorous on endoscopic examination, have corresponding appearances on rectal EUS as single, multiple, and innumerable submucosal veins, respectively. The hemodynamic evaluation (HDE) of RVs by EUS is routinely done at some centers to assess parameters like the site, size, velocity, or direction of flow.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AIM:

To describe the clinical, radiological, endoscopic and endoscopic-ultrasound features of non-bleeding and bleeding rectal varices, among patients with portal hypertension.

OBJECTIVES:

Primary objectives:

Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension Secondary objectives

  1. Etiological spectrum of bleeding per-rectum, among patients with PHT.
  2. Frequency of coexistence of hemorrhoids with RV.
  3. Distribution and size of variceal channels in the rectum on endoscopy and endoscopic ultrasound (EUS).
  4. Location and numbers of inflow and outflow perforator channels for RV on endoscopic ultrasound (EUS).

Patients and methodology

Study Population:

All patients with PHT (cirrhotic or non-cirrhotic), with active or prior anorectal bleeding (defined later) in the preceding 6-months will be evaluated for inclusion. We will also include patients with incidental detection of RV during endoscopy done for other indications. We will include both indoor and outdoor patients, attending the Department of Hepatology, ILBS, New Delhi. An informed consent will be obtained from the participants in the study.

Study Design Cross- sectional, observational and descriptive study

Study period September 2020 to February 2020. Baseline data

The following clinical, biochemical and radiological features will be recorded (detailed in the proforma):

  1. Liver disease etiology and severity, including Fibroscan and HVPG, where done.
  2. Upper endoscopy findings.
  3. Details of prior bleeding episodes if any (upper and lower).
  4. Details of current bleeding episodes.
  5. Radiological features (cirrhosis, splanchnic venous thrombosis, flow direction in portal vein (PV) and its tributaries, inferior mesenteric vein (IMV) diameter, enlarged para-rectal collateral circulation, large porto-systemic shunts).

Endoscopy protocol:

All patients will undergo a sigmoidoscopy or colonoscopy procedure, as per the clinical indication. Patients found to have RV will undergo EUS examination in addition. EUS evaluation of patients with hemorrhoids alone will be done at the discretion of the examiner after informed consent from the patient.

Bowel preparation: Patient will be advised liquid-soft diet for 24 hours before the examination day. Split dose PEG preparation (2-4 L volume) will be administered- 2L in evening before and 2L on day of procedure till 4hours before the study scheduled time.

Patient position: Left lateral position. Endoscopes: Colonoscope or gastroscope. EUS probes: Radial and linear EUS scopes, paired with Olympus compact EUS processor EU-M2.

Operators: Procto-sigmoidoscopy: HS supervised by VB/ VB EUS: VB/ HS supervised by VB

Study Definitions:

Lower GI bleeding LGIB will be defined as bleeding from a source distal to the ileocecal valve (24).

Acute lower gastrointestinal bleeding Acute LGIB will be defined as bleeding of recent duration (<3 days) that may result in hemodynamic instability, anemia, and/or the need for blood transfusion (25).

Clinically significant lower gastrointestinal bleeding[VB1] Requirement for blood transfusion, a hemoglobin drop of > 3g/dL from baseline or need for hospital admission.

A bleeding episode is clinically significant when there is (BAVENO III[VB2] ):

1. Transfusion requirement of ≥ 2 units of blood within 24 hours of time zero, 2. Systolic blood pressure < 100 mmHg or a postural change of >20 mmHg, 3. Pulse rate >100/min at time zero Anorectal bleeding

  1. Anorectal bleeding will be defined as red bleed per-rectum without or with stool expulsion. In the latter instance it can be mixed with stools, may smear stool, may dribble after defecation, or may smear wipes.
  2. Anorectal bleeding may be painless or may be associated with pain.
  3. Anorectal bleeding may or may not be associated with hemodynamic changes.

Monitoring and assessment

Primary:

1. Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension

Secondary

  1. Etiological spectrum of bleeding per-rectum, among patients with PHT.
  2. Frequency of coexistence of hemorrhoids with RV.
  3. Distribution and size of variceal channels in the rectum on endoscopy and endoscopic ultrasound (EUS).
  4. Location and numbers of inflow and outflow perforator channels for RV on endoscopic ultrasound (EUS).

Statistical analysis The dependent variable in the study will be presence of RV, presence of large RV (>5mm), and RV bleeding. Independent variables will be presence/ absence of esophageal varices, gastric varices, ectopic varices, prior UGIE bleeding, prior endotherapy for esophago-gastric varices, ascites, gastro-lieno-renal shunt, other large porto-systemic shunt, PV and/or SV and/or SMV thrombosis or flow reversal, composite liver function scores (CTP and MELD), number, location, and size of rectal perforator channels, size of para-rectal collaterals, pulsatile/ phasic flow in perforator(s) and/or RV, and presence of hemorrhoids. The continuous data will be represented by Mean ± SD or by Median (IQR) as appropriate. The categorical data will be represented as frequency (%). Student t-test or Mann Whitney test will be used for quantitative data and Chi square test will be used for qualitative data. Besides this an appropriate statistical analysis like uni-variate and multi-variate logistic regression will be used at the time of data analyss. The significance will be seen at 5 %.

Adverse Event:

  1. Pain abdomen
  2. Bloating sensation
  3. Abdominal distension

Stopping Rule:No stopping rule

Ethical Issues in the study and plans to address these issues:No ethical issue related to my study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Recruiting
        • Institute of Liver & Biliary Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with PHT (cirrhotic or non-cirrhotic), with active or prior anorectal bleeding (defined later) in the preceding 6-months will be evaluated for inclusion. We will also include patients with incidental detection of RV during endoscopy done for other indications. We will include both indoor and outdoor patients, attending the Department of Hepatology, ILBS, New Delhi. An informed consent will be obtained from the participants in the study.

Description

Inclusion Criteria:

  1. Age >18-years.
  2. Patients with PHT and active or prior anorectal bleeding in preceding 6-months.
  3. Patients with RV (bleeding or non-bleeding) detected on LGI endoscopy.
  4. Ability to understand study procedures, and to comply with them for the entire length of the study.

Exclusion Criteria:

  1. Peri-anal infection, peri-anal warts, anal condyloma, or fistulizing disease.
  2. Proctitis- infective, inflammatory bowel disease (IBD), radiation, or unspecified.
  3. Pregnant or lactating females.
  4. Presence of hemodynamic instability.
  5. Presence of encephalopathy
  6. Non-consenting adult patient or guardian.
  7. Prior history of banding or surgery for hemorrhoids, or endotherapy for RV.
  8. Prior shunt occlusion procedures like BRTO or PARTO, or shunt creation procedures like TIPS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Rectal varices with bleed
Other: No intervention
No intervention
Rectal varices without bleed
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Etiological spectrum of bleeding per-rectum, among patients with PHT.
Time Frame: Day 1
Day 1
Frequency of coexistence of hemorrhoids with Rectal varices
Time Frame: Day 1
Day 1
Distribution and size of variceal channels in the rectum on endoscopy and endoscopic ultrasound (EUS).
Time Frame: Day 1
Day 1
Location and numbers of inflow and outflow perforator channels for RV on endoscopic ultrasound (EUS).
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILBS-PHT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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