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

Sponsors

Commanditaire principal: Renmin Hospital of Wuhan University

La source Renmin Hospital of Wuhan University
Bref résumé

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.

Description détaillée

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.

Situation globale Not yet recruiting
Date de début 2021-04-10
Date d'achèvement 2021-12-31
Date d'achèvement principale 2021-12-31
Type d'étude Observational
Résultat primaire
Mesure Plage de temps
five-day rebleeding rate 5 days after treatment
six-week mortality rate 6 weeks after treatment
Résultat secondaire
Mesure Plage de temps
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
Inscription 80
État
Intervention

Type d'intervention: Procedure

Nom de l'intervention: EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

La description: (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.

Étiquette du groupe d'armements: EUS-guided coil and cyanoacrylate injection

Type d'intervention: Procedure

Nom de l'intervention: balloon-occluded retrograde transvenous obliteration

La description: (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.

Étiquette du groupe d'armements: BRTO

Admissibilité

Méthode d'échantillonnage: Non-Probability Sample

Critères:

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

Le sexe: All

Âge minimum: 18 Years

Âge maximum: N/A

Volontaires en santé: No

Officiel général
Nom de famille Rôle Affiliation
Mingkai Chen, PHD Study Director Renmin Hospital of Wuhan University
Contact général

Nom de famille: Mingkai Chen, PHD

Téléphone: +86 13720330580

Email: [email protected]

Emplacement
Établissement: Contact: Mingkai Chen Mingkai Chen, PHD + 86 13720330580 [email protected]
Pays d'implantation

China

Date de vérification

2021-03-01

Partie responsable

Type: Principal Investigator

Affiliation des enquêteurs: Renmin Hospital of Wuhan University

Nom complet de l'enquêteur: ChenMingkai

Titre d'enquêteur: Professor

A un accès étendu No
Parcourir l'état
Groupe d'armes

Étiquette: EUS-guided coil and cyanoacrylate injection

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

Étiquette: BRTO

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

Données patient Undecided
Informations sur la conception de l'étude

Modèle d'observation: Cohort

Perspective temporelle: Retrospective

La source: ClinicalTrials.gov

Clinical Research News