Endoscopic ultrasound guided portal pressure measurement to predict the outcome of liver resectio
Not Applicable
- Conditions
- Portal HypertensionLiver CirrhosisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12621000464864
- Lead Sponsor
- Royal Adelaide Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1) Patients (with or without cirrhosis) who are recommended for liver resection or liver transplant
2) Patients with cirrhosis who are recommended to undergo abdominal surgery
Exclusion Criteria
1) International Normalised Ratio (INR) > 1.6
2) Significant ascites
3) Child-Pugh C severity of cirrhosis
4) Presence of large gastric varices or periportal collateral vessels that prevent EUS approach to the hepatic and/or portal vasculature
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy between EUS-PPGM and TJ-HVPG measurements. The accuracy of the EUS-PPG in predicting Post hepatectomy liver failure will be assessed by measuring the area under the receiver operating characteristics (AUROC) curve, and differences between AUROCs will be compared using the Hanley-McNeil method. Post-operative liver dysfunction is define as:<br>(i) serum bilirubin level > 5 mg/dL (> 85.5 umol/L) on or after postoperative day 5; (ii) coagulopathy (INR > 2.0 associated with haemorrhagic complications requiring transfusion); (iii) hepatic encephalopathy; and (iv) abdominal ascites (drainage volumes more than 500 mL/day after day 3).<br>[Procedural details will be collected immediately after procedure, and within 24 hours and 7 days post-procedure.]
- Secondary Outcome Measures
Name Time Method To compare the safety between EUS-PPGM and TJ hepatic venous pressure gradient measurements. This will include data on intraprocedural or postprocedural complications such as bleeding, perforation, pain, infection, need for transfusion, and length of hospital stay. The data will be collected from electronic medical records and hospital records. [Details will be collected immediately after procedure, 24 hours post procedure and/or following discharge from hospital. <br>];To compare cost differences between EUS PPGM and TJ HVPG technique approaches. Costs will be assessed via hospital medical records, and by calculating the differences between the resources used.[This will be assessed within 48 hours following procedure.];90-day mortality of participant. [This will be assessed at 90 day follow up with investigator following their procedure.]