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Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis (PU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04140591
Recruitment Status : Terminated (1. Most patients with liver cirrhosis already use PPI and NSBB 2. 90 % Peptic ulcer size is smaller than 5cm)
First Posted : October 28, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Brief Summary:
Proton pump inhibitor plus propranolol versus proton pump inhibitor alone on peptic ulcer healing in patients with liver cirrhosis: a randomized trail

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Peptic Ulcer Drug: Proton-pump inhibitor Drug: Propranolol+Proton-pump inhibitor Phase 2 Phase 3

Detailed Description:
Portal hypertension is responsible for the development of portosystemic collaterals. The hemodynamic alternations may result in mucosal and vascular changes along gastrointestinal (GI) tract as well. According to several epidemiological studies, cirrhotic patients are at a higher risk of developing peptic ulcers, delayed healing, and a higher frequency of ulcer recurrence. The death rate from peptic ulcer disease in cirrhotic patients has been reported to be five times higher than that of the general population. The exact mechanism remains incompletely understood, but may be related to impaired mucosal defense mechanisms. Aggressive factors such as Helicobacter pylori and gastric acid may not be the predominant etiology in such circumstances. Sarfeh et al. found gastric mucosa of portal hypertensive rats, compared with that of controls, has distinctive functional and histologic abnormalities that can explain its increased susceptibility to erosive injury. Auroux et al. found gastroduodenal ulcer was independently associated only with the severity of the hypertensive gastropathy in cirrhotics. Chen et al. found portal hypertension with a hepatic venous pressure gradient > 12 mmHg may be an important factor contributing to the increased prevalence of gastric ulcer observed in patients with liver cirrhosis. Thereby, we presumed that clinically significant portal hypertension may play a role in development of peptic ulcer in cirrhotic patients. Lebrec et al. elucidated non-selective beta-blocker (NSBB) could significantly decrease portal pressure and lower the risk of GI bleeding in patients with cirrhosis. Kitano et al. found portal hypotensive treatment with NSBB, reduces ethanol-induced gastric mucosal damage in portal hypertensive rats and improves endoscopic signs of portal hypertensive gastropathy in cirrhosis patients. We designed a 2-year randomized trial to evaluate the effectiveness of proton pump inhibitor with or without propranolol on ulcer healing and the incidence of ulcer bleeding in patients with cirrhosis and peptic ulcers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis: a Randomized Trail
Actual Study Start Date : December 26, 2016
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Proton-pump inhibitor
PPI: Pariet EC 20 mg/QDAC
Drug: Proton-pump inhibitor
PPI: Pariet EC 20mg/QDAC
Other Names:
  • Pariet EC
  • PPI

Active Comparator: Propranolol+Proton-pump inhibitor

Propranolol:

Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)

PPI: Pariet EC 20 mg/QDAC

Drug: Propranolol+Proton-pump inhibitor
Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure >90mmHg) PPI: Pariet EC 20mg/QDAC
Other Names:
  • Inderal
  • Cardolol




Primary Outcome Measures :
  1. Healing of peptic ulcer [ Time Frame: 2 months ]
    if propranolol can help cure peptic ulcer

  2. Bleeding rate of peptic ulcer [ Time Frame: 2 months ]
    if propranolol can help decrease the rate of ulcer bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 20 and 85 years old
  • Liver cirrhosis associated with esophageal varices or gastric varices
  • Gastric ulcer or duodenal ulcer ,size bigger or egual than 0.5 cm

Exclusion Criteria:

  • Acute bleeding
  • Steroid or NSAID user
  • Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
  • Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140591


Locations
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Taiwan
Taipei Veterans General Hospital, Taiwan
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Ming-Chih mchou@vghtpe.gov.tw, MD Institutional Review Board, Taipei Veterans General Hospital, Taiwan
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Responsible Party: vghtpe user, The Division of Gastroenterology & Hepatology, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04140591    
Other Study ID Numbers: V106C-137
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
Portal hypertension
Peptic ulcer
Non-selective beta-blocker
Proton pump inhibitor
Additional relevant MeSH terms:
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Liver Cirrhosis
Peptic Ulcer
Ulcer
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Stomach Diseases
Propranolol
Proton Pump Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Enzyme Inhibitors