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Sequential therapy with esophageal varice ligation and sclerotherapy compared with ligation alone on the obliteration and recurrence of esophageal varices in patients with decompensated cirrhosis-A randomized double-blinded controlled study

Sequential therapy with esophageal varice ligation and sclerotherapy compared with ligation alone on the obliteration and recurrence of esophageal varices in patients with decompensated cirrhosis-A randomized double-blinded controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16007964
Enrollment
Unknown
Registered
2016-02-22
Start date
2016-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cirrhosis with esophageal varices

Interventions

ligation alone group:undergoing regular ligation therapy until the obliteration of varice
???????????=0.6cm??????????????:undergoing regular sclerotherapy with diameter of varices=0.6cm after ligation until the obliteration of varices

Sponsors

The first affiliated hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Consecutive patients with decompensated cirrhosis and esophageal varices, with the age between 18-65 years old; 2. Patients underwent endoscopic varices ligation therapy within 1 year, with current diameter of esophageal varices<=0.6cm; 3. All the enrolled patients signed informed consent.

Exclusion criteria

Exclusion criteria: 1. With liver cancer (>stage B in Barcelona Clinic Liver Cancer staging classification) or other malignancy; 2. With gastric varices or other ectopic varices; 3. With severe illness in heart, brain, lung or kidney, such as stroke, uremia, acute coronary syndrome, respiratory failure or type I hepatorenal syndrome; 4. No tolerance to endoscopy; 5. Transjugular intrahepatic portosystemic stent shunt or surgery before entry; 6. Total bilirubin>170umol/L or Child-Pugh score>13; 7. Without cirrhosis; 8. Use of sclerotherapy or cyanoacrylate 1 year before entry.

Design outcomes

Primary

MeasureTime frame
The time to esophageal variceal recurrence;

Secondary

MeasureTime frame
re-bleeding rate after 6 wks and 1 year of index endoscopic therapy;mortality after 6 wks and 1 year of index endoscopic therapy;The time to esophageal variceal obliteration;The number of endoscopic therapy sessions until the obliteration of varices;

Countries

China

Contacts

Public ContactAnjiang Wang
waj1103b@163.com+86 13627002546

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026