An interventional study of diet management strategy for encephalopathy in Hepatic Encephalopathy, sponsored by Li Yang. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by Li Yang · Not applicable, Interventional, and Treatment
Among 26 studies in Hepatic Encephalopathy with a site in China — 16 open to participants now, 18 under way, none of them phase 3. Hepatic Encephalopathy · China.
Among the 26 studies in Hepatic Encephalopathy with a site in China, this one is the 10th largest by planned enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2017, is one of 11 with no phase, and was the 4th registered.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
Browse Hepatic Encephalopathy studies →16 of the 26 studies in Hepatic Encephalopathy with a site in China are open now. Recruiting first, the newest first:
Air Force Military Medical University, China · Sites in China
Ages 18+
Air Force Military Medical University, China · Sites in China
Ages 18–75 · Healthy volunteers
Air Force Military Medical University, China · Sites in China
Ages 18–75
General Hospital of Shenyang Military Region · Sites in China
Ages 18+
The Second Affiliated Hospital of Chongqing Medical University · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 30 Hepatic Encephalopathy studies recruiting now, 12 (40%) set no upper age limit and 13 (43%) stop at 75 or younger; 1 takes children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 1 · Phase 3 1 · Phase 4 2
First in 2014; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 86 is above the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Median enrollment 100 across the 17 interventional studies, 252 across the 9 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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None of the 26 has an industry lead sponsor. The 10 most frequent:
Li Yang is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Li Yang has 1 study filed under Hepatic Encephalopathy — fewer than ten, so there is no comparison to draw.
4 of the studies in Hepatic Encephalopathy with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07683936Air Force Military Medical University, ChinaFecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS Surgery | 2027-01-31 |
| NCT07273734West China HospitalUDCA to Prevent Post-TIPS Hepatic Encephalopathy | 2027-06-30 |
| NCT06483737General Hospital of Shenyang Military RegionHuman Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) | 2027-06-30 |
| NCT07852416The First Affiliated Hospital with Nanjing Medical UniversityElectronic PHES vs Paper-based PHES for Hepatic Encephalopathy | 2027-09-01 |
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Among the 26 studies in Hepatic Encephalopathy with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Hepatic encephalopathy is a severe complication of transjugular intrahepatic portosystemic shunt (TIPS) treatment in patients with cirrhosis and variceal bleeding. This study is specially designed to explore whether diet management strategy could decrease incidence of encephalopathy after TIPS treatment.
Hepatic encephalopathy (HE) is a severe complication of TIPS treatment in patients with cirrhosis and variceal bleeding. The overall incidence of post-TIPS encephalopathy ranges between 10% and 50%, and even the percentage of the new or worsened HE was evaluated up to 13-36%. No approach or medication was evidenced for prophylaxis of post-TIPS encephalopathy, including lactulose and rifaximin. Diet management has been used as an important part of the prophylaxis and treatment strategy for patients with metabolic diseases like diabetes and nephritis, which has drawn increasing interest of clinicians. Nevertheless, there is still no standard consensus or even recommendation for patients after TIPS procedure for now, which worsened malnutrition and affected survival. Thus, this study is specially designed to explore whether diet management strategy, drawn up from the nutritional management consensus of hepatic encephalopathy (ISHEN consensus), could decrease incidence of encephalopathy after TIPS treatment of the patient with cirrhosis and variceal bleeding.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
diet management strategy for encephalopathy
Dietary Supplement: diet management strategy for encephalopathy
Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department
diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.
Incidence of Hepatic Encephalopathy
incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment
Time frame: 1 year
Liver Transplantation-free Survival Rate
survival rate free of liver transplantation within 1 year after enrollment
Time frame: 1 year
Incidence of Stent Dysfunction
Narrowing or even complete occlusion of the stent, evidenced by imaging examination and/or upper gastrointestinal endoscopy, with or without clinic symptoms.
Time frame: 1 year
Incidence of Portal Hypertension Related Severe Complications
Incidence of severe complications of portal hypertension, especially for failure of control of acute variceal bleeding and clinical significant rebleeding.
Time frame: 1 year
Change of Nutritional Status
Human body components analysis, evaluated by score of the Inbody Test.
Time frame: 1 year
Change of Quality of Life
Health related quality of life, assessed by score of the widely used questionaire Short Form 36.
Time frame: 1 year
Plan to share: Undecided — The investigators need to discuss with other participants whether or not to share data of the study.
Started Oct 2017 (actual). Primary completion is estimated for Nov 2018, 13 months after the start.
Of 26 interventional studies with no phase under Hepatic Encephalopathy, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 72. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Li Yang