"To Study the Impact of Balloon-occluded Retrograde Transvenous Obliteration (BRTO)/Plug Assisted Retrograde Transvenous Obliteration (PARTO) Mediated Portal Flow Modulation in Reduction of Ammonia and Improvement in Organ Volume and Functionality in Patients of Cirrhosis With LR Shunt
NCT04089878, Not applicable, Unknown, Institute of Liver and Biliary Sciences, India
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | "To Study the Impact of Balloon-occluded Retrograde Transvenous Obliteration (BRTO)/Plug Assisted Retrograde Transvenous Obliteration (PARTO) Mediated Portal Flow Modulation in Reduction of Ammonia and Improvement in Organ Volume and Functionality in Patients of Cirrhosis With LR Shunt | ClinicalTrials.gov |
| NCT number | NCT04089878 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Institute of Liver and Biliary Sciences, India | ClinicalTrials.gov |
| Conditions | Liver Cirrhoses | ClinicalTrials.gov |
| Interventions | Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration, Standard Medical Treatment | ClinicalTrials.gov |
| First posted | 2019-09-13 | ClinicalTrials.gov |
| Last updated | 2019-11-13 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Improvement in covertHepatic Encephalopathy in both groups. | 1 year | Covert HE or overt HE will be analysed using clinical examination(west haven grading), specialised tests like stroop test, CFF(critical flicker frequency) or in rare cases EEG can be done. | ClinicalTrials.gov |
| Secondary | Change in ammonia level in both groups | 1 year | ClinicalTrials.gov | |
| Secondary | Incidence of ascites in both groups | 1 year | Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension. | ClinicalTrials.gov |
| Secondary | Incidence of acute variceal bleed in both groups. | 1 year | Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension. | ClinicalTrials.gov |
| Secondary | Number of participants with Liver transplant or death in both groups. | 1 year | ClinicalTrials.gov | |
| Secondary | Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups. | 6 months | MELD: A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list.A MELD score is a number that ranges from 6 to 40, based on lab tests. | ClinicalTrials.gov |
| Secondary | Change in CTP (Child-Pugh score) by 2 points improvement in both groups. | 6 months | CTP- Child-Turcotte-Pugh score is ranges from 5 to 15, lowest is best and highest is worst . | ClinicalTrials.gov |
| Secondary | Changes in portal flow in both groups. | 1 year | Change will be measured by ICG and Doppler study tests. | ClinicalTrials.gov |
| Secondary | Number of patients with prevention of Gastro-Variceal bleed in both groups. | 1 year | It is a clinical outcome and it will be assessed by history and will be confirmed and managed by endoscopic procedure. | ClinicalTrials.gov |
| Secondary | Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups. | 1 year | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)