Efficacy and Safety of EUS-guided Coil Combined With Endoscopic Cyanoacrylate Injection Versus BRTO in Patients With Spontaneous Portosystemic Shunt

Efficacy and Safety of EUS-guided Coil Combined With Endoscopic Cyanoacrylate Injection Versus BRTO in the Treatment of Gastric Varices With Spontaneous Portosystemic Shunt

Sponsoren

Hauptsponsor: Renmin Hospital of Wuhan University

Quelle Renmin Hospital of Wuhan University
Kurze Zusammenfassung

This study is a retrospective, multi-center and observational clinical study. Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The fifth medical center of PLA General Hospital, Zhongshan Hospital, Fudan University, Shanghai, Nanjing Drum Tower Hospital affiliated Nanjing University Medical School and Xiangyang Central Hospital will participate in the study. Investigators would like to provide evidence-based medical evidence by evaluating and comparing the efficacy and safety of endoscopic ultrasound (EUS)-guided coil embolization combined with endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous obliteration (BRTO) in the treatment of gastric varices (GV) with spontaneous portosystemic shunt (SPSS). Between January 2014 and December 2020, patients with GV secondary to portal hypertension admitted to a tertiary medical center, are enrolled consecutively according to the following criteria: (1) age≥18 years; (2)endoscopic examination confirms the presence of GV; (3) CTA of the portal system and EUS revealed the presence of SPSS, the diameter was between 5 mm to 15 mm; (4) treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO. Exclusion criteria are as follows: (1)malignant tumors; (2) hepatic encephalopathy, hepatorenal syndrome or multiple organ failure; (3) previously received esophagus or stomach surgery; (4) pregnant. Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until the progress of the disease or the end of the study. And rebleeding, ectopic embolism, survival, and sequential treatment will be recorded during the follow-up period. The primary endpoint are five-day rebleeding rate and six-week mortality rate. The secondary endpoint are: technical success rate, incidence of ectopic embolism, eradication of GV, one-year rebleeding rate, rescue treatment, cost-effectiveness ratio and sequential treatment. All data and information use SPSS statistical software to complete all statistical analysis.

detaillierte Beschreibung

Because the efficacy and safety of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection and BRTO in the treatment of GV with SPSS have different conclusions in different studies. Investigators based on that the five-day rebleeding rate of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection is 7%, BRTO is 10%. The number of people in the two groups are equal, significant level (α) is 0.05, and the test power is 0.8. Each group requires 35 patients. Because of the 10% loss to follow-up, the sample capacity is 39.

Gesamtstatus Not yet recruiting
Anfangsdatum 2021-04-10
Fertigstellungstermin 2021-12-31
Primäres Abschlussdatum 2021-12-31
Studientyp Observational
Primärer Ausgang
Messen Zeitfenster
five-day rebleeding rate 5 days after treatment
six-week mortality rate 6 weeks after treatment
Sekundäres Ergebnis
Messen Zeitfenster
technical success rate in the procedure of treatment
incidence of ectopic embolism up to 3 years after treatment
eradication of gastric varices 1 year after treatment
one-year rebleeding rate 1 year after treatment
requirement of sequential treatment up to 3 years after treatment
Einschreibung 80
Bedingung
Intervention

Interventionsart: Procedure

Interventionsname: EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

Beschreibung: (1) Standard diagnostic endoscopy was first performed. Fundal varices were assessed using the classification of Sarin's. (2) intraluminal water filling of the gastric fundus to use EUS to assess the anatomy of gastric varices, observe the blood flow, scan the portal venous system, left renal vein, confirm the location of the shunt, and measure the diameter of the shunt. (3) Punctured the gastric fundal variceal vein at the lower esophagus near the cardia and placed the coil into the shunt and immediately injected with sclerosant and cyanoacrylate under the guidance of EUS. (4) Sclerosant and cyanoacrylate were injected into the gastric fundal varices by a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. (5) After the injection, use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect.

Armgruppenetikett: EUS-guided coil and cyanoacrylate injection

Interventionsart: Procedure

Interventionsname: balloon-occluded retrograde transvenous obliteration

Beschreibung: (1)A balloon occlusive catheter was inserted into the shunt via the right femoral vein. (2)Investigators performed angiography to evaluate the size and location of GV and the shunt during balloon occlusion. Shunt was occluded by Fogarty balloon. The diameter of the balloon was chosen according to the diameter of shunt. (3)Then investigators injected sclerosant into the portosystemic shunt. (4)Finally, the balloon left in place for 24 hours was gradually deflated when complete occlusion of blood flow of the target shunt was achieved.

Armgruppenetikett: BRTO

Teilnahmeberechtigung

Probenahmeverfahren: Non-Probability Sample

Kriterien:

Inclusion Criteria: - age≥18 years - endoscopic examination confirmed the presence of gastric varices - CTA of the portal system and EUS revealed the presence of spontaneous portosystemic shunt (SPSS) that the diameter was between 5 mm to 15 mm - treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO Exclusion Criteria: - malignant tumors - hepatic encephalopathy, hepatorenal syndrome or multiple organ failure - previously received esophagus or stomach surgery - pregnant

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Mingkai Chen, PHD Study Director Renmin Hospital of Wuhan University
Gesamtkontakt

Nachname: Mingkai Chen, PHD

Telefon: +86 13720330580

Email: [email protected]

Ort
Einrichtung: Kontakt: Mingkai Chen Mingkai Chen, PHD + 86 13720330580 [email protected]
Standort Länder

China

Überprüfungsdatum

2021-03-01

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Renmin Hospital of Wuhan University

Vollständiger Name des Ermittlers: ChenMingkai

Ermittlertitel: Professor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: EUS-guided coil and cyanoacrylate injection

Beschreibung: Patients who received EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

Etikette: BRTO

Beschreibung: Patients who received balloon-occluded retrograde transvenous obliteration (BRTO)

Patientendaten Undecided
Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Retrospective

Quelle: ClinicalTrials.gov

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