Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04535440 |
| Other study ID # |
ILBS-PHT-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2021 |
| Est. completion date |
July 31, 2022 |
Study information
| Verified date |
October 2021 |
| Source |
Institute of Liver and Biliary Sciences, India |
| Contact |
Dr Hitesh Singh, MD |
| Phone |
01146300000 |
| Email |
hiteshrims04[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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
