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Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00635310
First received: March 5, 2008
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose
Percutaneous liver biopsy (PLB) is the gold standard for grading necroinflammation and staging fibrosis in patients with chronic viral hepatitis. Whether the use of 1-deamino-8-D-arginine vasopressin (DDAVP) before PLBs in hemodialysis (HD) patients with chronic viral hepatitis has comparable safety profiles to those with normal renal function (NRF) has not been evaluated in prospective studies.

Condition Intervention
Chronic Hepatitis C
Chronic Hepatitis B
Biopsy
Hemodialysis
 Procedure: Percutaneous liver biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 3520
Study Start Date: January 2005
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HD patients with CHC or CHB
Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with hemodialysis (HD), pretreated with DDAVP 0.3 ug/kg body weight infusion 30-60 minutes before percutaneous liver biopsies (PLBs)
 Procedure: Percutaneous liver biopsy
Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)
Active Comparator: Ordinary patients with CHC or CHB
Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with normal renal function (NRF) receiving percutaneous liver biopsies (PLBs)
 Procedure: Percutaneous liver biopsy
Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)

Detailed Description:

Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. Currently, percutaneous liver biopsy (PLB) remains the gold standard for grading necroinflammation and staging fibrosis in patients with liver diseases. In addition, liver histology can help clinicians determine the eligibility of renal transplantation, prognosis, and necessity of antiviral therapy in dialysis patients with chronic viral hepatitis. In chronic hepatitis patients with normal renal function (NRF), the risks of fatal and non-fatal hemorrhage after liver biopsies for non-malignant diseases were 0.04% and 0.16%, respectively. However, the relative risks of post-biopsy hemorrhage in CHC patients with end-stage renal disease to those with NRF remain disputed.

Deamino-8-D-arginine vasopressin (DDAVP), a synthetic analogue of vasopressin, is a commonly used hemostatic agent to treat uremic bleeding by inducing the release of von Willebrand factor (vWF) and factor VIII from their storage sites in endothelial cells.Previous studies have shown that one dose of 0.3-0.4μg/kg body weight DDAVP infusion for dialysis patients could normalize bleeding time (BT), and prevent surgical and renal biopsy bleeding. Nevertheless, two recent studies showed divergent liver biopsy-related bleeding complication rates (0% and 6%, respectively) in dialysis CHC patients pre-treated with DDAVP. Since most studies evaluating the safety of PLB in CHC patients with dialysis were small and retrospective in nature, and not controlled by the biopsy route, the type of biopsy needle, the use of ultrasound guidance, or the number of passes,further studies are urgently needed to solve this important issue. Thus, we aimed to conducted a large clinical trial to compare the safety profiles of PLB between CHC patients with hemodialysis (HD) who were pretreated with DDAVP and those with NRF by the same biopsy technique.

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis C (presence of anti-HCV and serum HCV RNA > 6 months)
  • Chronic hepatitis B (presence of HBsAg > 6 months)
  • Receiving regular hemodialysis or normal renal function (Creatinine < 1.5 x ULN)
  • Receiving percutaneous liver biopsy (PLB)

Exclusion Criteria:

  • Human immunodeficiency virus (HIV) co-infection
  • Unwilling or contraindicated to receive percutaneous liver biopsy (PLB)
  • Receiving liver biopsy without ultrasound (US) guidance or automatic cutting needles
  • Did not receive 2 passes of liver biopsy
  • Inadequate record of post-biopsy complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635310

Contacts
Contact: Chen-Hua Liu, MD +886-2-23123456 ext 3572 jacque_liu@mail2000.com.tw

Locations
Taiwan
Chiayi Christian Hospital Recruiting
Chia-Yi, Taiwan
Contact: Peir-Haur Hung, MD         
Principal Investigator: Peir-Haur Hung, MD         
St. Martin De Porres Hospital Recruiting
Chia-Yi, Taiwan
Contact: Hung-Bin Tsai, MD         
Principal Investigator: Hung-Bin Tsai, MD         
National Taiwan University Hospital, Yun-Lin Branch Recruiting
Douliou, Taiwan
Contact: Shih-Jer Hsu, MD         
Principal Investigator: Shih-Jer Hsu, MD         
Principal Investigator: Jou-Wei Lin, MD         
Principal Investigator: Shih-I Chen, MD         
Principal Investigator: Jun-Herng Chen, MD         
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 100
Contact: Cheng-Chao Liang, MD         
Principal Investigator: Cheng-Chao Liang, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chen-Hua Liu, MD    +886-2-23123456 ext 3572    jacque_liu@mail2000.com.tw   
Principal Investigator: Chen-Hua Liu, MD         
Principal Investigator: Jia-Horng Kao, MD         
Principal Investigator: Chun-Jen Liu, MD         
Principal Investigator: Ming-Yang Lai, MD         
Principal Investigator: Pei-Jer Chen, MD         
Principal Investigator: Ding-Shinn Chen, MD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Chen-Hua Liu, MD National Taiwan University Hospital
Principal Investigator: Jia-Horng Kao, MD National Taiwan University Hospital
Principal Investigator: Chun-Jen Liu, MD National Taiwan University Hospital
Principal Investigator: Ming-Yang Lai, MD National Taiwan University Hospital
Principal Investigator: Pei-Jer Chen, MD National Taiwan University Hospital
Principal Investigator: Ding-Shinn Chen, MD National Taiwan University Hospital
Principal Investigator: Cheng-Chao Liang, MD Far Eastern Memorial Hospital
Principal Investigator: Shih-Jer Hsu, MD National Taiwan University Hospital, Yun-Lin Branch
Principal Investigator: Jou-Wei Lin, MD National Taiwan University Hospital, Yun-Lin Branch
Principal Investigator: Shih-I Chen, MD National Taiwan University Hospital, Yun-Lin Branch
Principal Investigator: Hung-Bin Tsai, MD St. Martin De Porres Hospital
Principal Investigator: Peir-Haur Hung, MD Chia-Yi Christian Hospital
Principal Investigator: Jun-Herng Chen, MD National Taiwan University Hospital, Yun-Lin Branch
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00635310     History of Changes
Other Study ID Numbers: 940211 
Study First Received: March 5, 2008
Last Updated: December 19, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Chronic hepatitis C
Chronic hepatitis B
Liver biopsy
Hemodialysis
1-Deamino-8- D-Arginine Vasopressin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis B
Hepatitis C, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Liver Extracts
Vasopressins
Arginine Vasopressin
Deamino Arginine Vasopressin
Hematinics
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016