The Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding

• ClinicalTrials.gov Identifier: NCT03683121
• Recruitment Status: Recruiting
• First Posted: September 25, 2018
• Last Update Posted: March 23, 2021
• Sponsor: Renmin Hospital of Wuhan University
• Information provided by (Responsible Party): ChenMingkai, Renmin Hospital of Wuhan University

Study Description

Brief Summary:

Non-selective beta blockers are commonly used drugs for primary prevention and secondary prevention in patients with cirrhotic decompensated esophageal varices bleeding，the basic heart rate, blood pressure and condition of different patients have individual differences.This paper mainly discusses the compliance of patients taking NSBB under different follow-up methods and analyze the factors affecting patient compliance.

Condition or disease
Esophageal Varices Bleeding

Detailed Description:

Esophagogastric variceal hemorrhage is a common complication of decompensated liver cirrhosis and the rate of rebleeding after hemostasis is high.Effective secondary prevention reduces the risk of rebleeding.Non-selective beta blockers are commonly used drugs for secondary prevention.Clinically, there is a great difference in the compliance of patients taking non-selective beta receptor blockers.In this study, the enrolled patients were divided into three groups: the traditional follow-up group (face-to-face interview);Non-traditional follow-up (WeChat, telephone, etc.);Traditional and non-traditional methods of follow-up were combined in the group.The investigators collected the basic data before the patients were enrolled, adjusted the medication dosage according to the patients' condition during the follow-up period, and recorded the treatment during the follow-up period, and analyzed the factors influencing the patients' compliance.

Study Design

• Study Type: Observational
• Estimated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Different Follow-up Methods on Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
• Actual Study Start Date: July 1, 2018
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Groups and Cohorts

Group/Cohort
the traditional follow-up group; The dose and notes for the use of the Non-selective beta blockers were informed during outpatient follow-ups for the patients with a history of esophageal variceal bleeding
Non-traditional follow-up; The dose and notes for the use of the Non-selective beta blockers were informed during telephone or WeChat follow-ups for the patients with a history of esophageal variceal bleeding
Combine of Group1 and Group2; The dose and notes for the use of the Non-selective beta blockers were informed during outpatient follow-ups for the patients with a history of esophageal variceal bleeding,and the patients were followed up by telephone or WeChat again on the same day.

Outcome Measures

Primary Outcome Measures :

1. Heart rate compliance ratio after treatment with NSBBs [ Time Frame: 10 months ]
   In this single-center study, 83 patients were included, including 9 cases lost to follow-up, 1 case died, and 1 case was excluded from liver cancer. a total of 72 cases were included, with an average follow-up time of 185.3 days.Among the 72 patients who were not lost to follow-up, 40 NSBBs patients had good medication compliance, and 34 patients achieved heart rate response (34/40,85.0%).

Secondary Outcome Measures :

1. Different follow-up methods were used to guide non-hospitalized patients to take medication in NSBBs, and the compliance of patients with NSBBs and its influencing factors were analyzed [ Time Frame: 10 months ]
   Three follow-up methods guided secondary prevention of NSBBs, and the compliance of patients in the remote platform follow-up group and the outpatient clinic combined with the remote platform follow-up group was higher than that in the outpatient follow-up group (P < 0.05).There was no statistically significant difference in patient compliance between the remote platform follow-up group and the outpatient combined remote platform follow-up group.In outpatient follow-up, there was a statistically significant difference between the subgroup of NSBBs with good compliance and poor compliance, and the local resident patients had better compliance
2. The compliance of gastroscopy and bleeding of esophageal and gastric varices during the follow-up period were analyzed [ Time Frame: 10 months ]
   The compliance of the subgroup of NSBBs with good medication compliance was 30/40 (75.0%) during the follow-up period of gastroscopy, and 14/30 (46.7%) after gastroscopy was followed up for sequential endoscopic treatment.Poor compliance of NSBBs subgroup during the follow-up period, the compliance of gastroscopy was 7/32 (21.9%), and 3/7 (42.9%) after gastroscopy, sequential treatment under endoscopy.During the follow-up period, the subgroup with good medication compliance of NSBBs had higher compliance with gastroscopy than the subgroup with poor medication compliance (P=0.000).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The patient was diagnosed with liver cirrhosis in the investigator's hospital or the outer court and had a history of esophageal variceal rupture and bleeding before into the group

Criteria

Inclusion Criteria:

1. Signed informed consent
2. All cases met the diagnostic criteria for cirrhosis
3. All patients were confirmed to be combined with esophageal and gastric varices through endoscopy or portal vein CTA or abdominal CT, and had at least one history of esophageal and gastric varices rupture and bleeding. Child-pugh was graded as A/B.
4. All patients had basal heart rate greater than 60 beats/min and systolic pressure greater than 90mmhg.

Exclusion Criteria:

1. Patients with liver cancer or other gastrointestinal tumors
2. Patients with splenomegaly due to extrahepatic portal hypertension and noncirrhosis
3. Patients with basal heart rate less than 55 beats/min or systolic pressure less than 90mmhg
4. There are patients with NSBB contraindications such as severe cardiac insufficiency, cardiogenic shock, sinus bradycardia and morbid sinus syndrome, severe ventricular conduction block, bronchial asthma, etc.
5. Patients with other diseases other than liver cirrhosis should take beta blockers (such as coronary heart disease, arrhythmia, etc.).
6. Patient data is incomplete, data cannot be collected and counted
7. Patients who do not agree with secondary prevention after informing them about the adverse reactions associated with medication

Contacts and Locations

Locations

China, Hubei

Renmin Hospital of Wuhan University; Recruiting

Wuhan, Hubei, China, 430060

Contact: Mingkai Chen, doctor 13720330580 kaimingchen@163.com

Sponsors and Collaborators

Renmin Hospital of Wuhan University

More Information

• Responsible Party: ChenMingkai, Chief physician of Department of Gastroenterology I, Renmin Hospital of Wuhan University
• ClinicalTrials.gov Identifier: NCT03683121
• Other Study ID Numbers: ChenMingkai
• First Posted: September 25, 2018
• Last Update Posted: March 23, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ChenMingkai, Renmin Hospital of Wuhan University:

Esophagogastric variceal hemorrhage; cirrhosis; secondary prevention; Non-selective beta blocker; compliance

Additional relevant MeSH terms:

Esophageal and Gastric Varices; Varicose Veins; Hemorrhage; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Hypertension, Portal