Ignite Creation Date:
2024-05-06 @ 10:30 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03277937
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2017-07-18
Brief Title:
Angiography for Evaluation of the Feeder Vessel in EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices
Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Organization:
Instituto Ecuatoriano de Enfermedades Digestivas
Study Overview
Official Title:
The Use of Angiography for Determination and Confirmation of the Feeder Vessel as a Modification of the Original EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
INTRODUCTION Bleeding from gastric varices GV is associated with a high mortality rate Injection of cyanoacrylate CYA using standard gastroscope has demonstrated to achieve higher hemostasis and lower rebleeding rates compared to band ligation or sclerotherapy Nevertheless CYA treatment is known to be associated with significant adverse events Pulmonary embolism due to CYA injection is a serious and sometimes fatal complication of this therapy These patients usually have respiratory symptom however this complication can be present in asymptomatic patients being demonstrated only by a pathological CT scan On the other hand it has been described that the risk of glue embolism dependent on the volume of CYA injected being significantly greater with high volumes Other complications related to CYA injection are hemorrhage from injection site ulcers fever peritonitis needle impaction and even death Also the injection material can cause serious damage to the endoscope
Currently endoscopic injection of CYA can be performed by direct visualization using a standard gastroscope or guided by Endoscopic Ultrasound EUS with injection of CYA alone or in combination with coils The injection of coils in conjunction with CYA may reduce or eliminate the risk of glue embolization as coils can function as a scaffold to retain CYA within the varix and may decrease the amount of glue injection needed to achieve obliteration It has been previously demonstrated that treatment under EUS guidance may have some benefits It allows a precise targeting of the varix lumen or afferent feeding veins being the vessel obstructed with less amount of CYA than used for the blind injection by standard endoscopy reducing the risk of glue embolism EUS can confirm varix obliteration by Doppler effect and also the visualization of GV is not impaired by blood or food in the stomach thus it can be used in the setting of active hemorrhage
Currently endoscopic injection of CYA can be performed by direct visualization using a standard gastroscope or guided by Endoscopic Ultrasound EUS with injection of CYA alone or in combination with coils The injection of coils in conjunction with CYA may reduce or eliminate the risk of glue embolization as coils can function as a scaffold to retain CYA within the varix and may decrease the amount of glue injection needed to achieve obliteration It has been previously demonstrated that treatment under EUS guidance may have some benefits It allows a precise targeting of the varix lumen or afferent feeding veins being the vessel obstructed with less amount of CYA than used for the blind injection by standard endoscopy reducing the risk of glue embolism EUS can confirm varix obliteration by Doppler effect and also the visualization of GV is not impaired by blood or food in the stomach thus it can be used in the setting of active hemorrhage
Detailed Description:
On the other hand despite the EUS-injection of coils and CYA have shown very promising results it is extremely important to have experience performing this technique as the injection in a wrong vessel could be catastrophic It has been develop in our unit a modification of Binmoellers original technique by performing the injection of coils and CYA by EUS and fluoroscopic guidance The performance of an angiography guided by EUS and under fluoroscopy evaluation represents a modification to the original technique that add some benefits 1 The injection of water-soluble contrast allows identifying the variceal flow and the afferent feeding vessel left gastric vein and avoiding splenic vessels embolization 2 Also if there is a shunt it can be detected and the injection of CYA can be avoided 3 In case of active bleeding the angiography allows visualizing which varix is bleeding and target the correct vessel
The aim of this study is to show the results and potential benefits by adding an angiography to the original EUS-guided injection of coils in combination with CYA technique to determinate and confirm the feeder vessel in GV treatment
MATERIALS AND METHODS
Study design It will be an interventional descriptive and prospective study performed in the Ecuadorian Institute of Digestive Disease IECED Omni Hospital Academic Tertiary Center Ecuador Patients have been included from July 2015 and will continue to be included up to October 2017 The study protocol and consent form has been approved by the institutional review board and will be conducted according to the declaration of Helsinki Written informed consent will be obtained from all subjects
Population selection inclusion and exclusion criteria Patients above 18 years old with gastric varices GV on the initial standard diagnostic upper endoscopy will be enrolled GV will be classified according to Sarin and Kumar classification Only gastro-esophageal varices type II GOV II fundal varices communicating with esophageal varices and isolated gastric varices type I IGV I fundal varices within a few centimeters of the gastric cardia will be included Gastro-esophageal varices type I GOV I will be excluded as they can be successfully treated by endoscopic band ligation Patients with active bleeding and history of previous bleeding due to GV secondary prophylaxis will be included as well as patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus The exclusion criteria will be pregnancy concurrent hepatorenal syndrome andor multi-organ failure platelet count less than 50000ml or International Normalized Rate INR 2 esophageal stricture splenic or portal vein thrombosis and allergy to iodine
Endoscopic Procedure and Technique All procedures will be performed in a hospital-based interventional endoscopy setting where radiology is available and by one endoscopist CRM under general anesthesia with tracheal intubation with the patient in supine position and using antibiotic prophylaxis EUS examination will be performed using a 38 mm working channel linear-array therapeutic echoendoscopes EG 3870UTK Pentax Hamburg Germany attached to an ultrasound console Avius Hitachi Tokyo Japan The echoendoscope will be positioned in the distal esophagus at the level of the cardia anterograde trans-esophageal transcrural approach to visualize the gastric fundus and intramural varices
Detection of the feeder vessel by EUS Once positioned water will be instilled to fill the gastric fundus in order to improve acoustic coupling and visualization of GV EUS color Doppler imaging will be used to allow direct visualization of the varices flow Following the gastric vessel and by using the fine-flow doppler color of the ultrasound console the vessel or vessels will be followed from the cardia distal part of the esophagus to the proximal part of the esophagus 2 to 3 cm above the cardia to detect the feeding vessel The feeding vessel is characterized by the convergence of all vessels Once the feeding vessel has been found a 19 gauge EUS-fine needle aspiration FNA Expect flexible Boston Scientific Marlborough USA will be used to access the vessel the stylet will be withdrawn and a 20 ml syringe with negative pressure will be used to evaluate blood return confirming intravascular location In order to prevent blood clotting of the needle tip 5 ml of saline solution will be instilled Moreover the flush with saline solution allows to confirm the flow of the gastric vessels under B-mode ultrasound visualization
Using angiography to confirm the target vessel feeder vessel and flow traject In the final diagnostic step an angiography will be performed using 5 to 10 mL of water-soluble contrast Ultravist Bayer Ecuador under fluoroscopic evaluation in order to ensure intravascular location and study varix flow direction afferent or efferent Angiography technical success will be measured determined as the possibility to define the flow trajectory vessel under fluoroscopy
EUS-guided deployment of Coils and Cyanoacrylate injection Finally patients will be treated by EUS-deployment of coils followed by CYA injection The intravascular embolization coils that will be used 10-16 mm coiled diameter 12-20 cm straight lengths 0035 inches diameter Nester Embolization Coil Cook Medical will be delivered into the vessel through the FNA needle using the stylet as a pusher Special attention will be paid not place the needle tip on the counter wall due to the risk of perforation bleed coil extrusion and to allow enough space for the coil to curl
The CYA that will be used is the 2-Octyl-CYA Dermabond Ethicon Piscataway NJ It will be injected always after the coils are deployed and then 1 mL of saline solution will be used to flush the glue completely through the needle The diameter 10-16 mm number of coils and the volume of the 2-Octyl-CYA injected will be calculated according to the diameter of the vessel measured on EUS and by the angiography of the vessel After 30 seconds once CYA has been solidified and the risk of bleeding on the puncturing site decrease the needle will be withdrawn Obliteration of the vessel will be confirmed 3 minutes later using Doppler imaging Complete obliteration of the treated varix will be defined as absence of Doppler flow on EUS
A direct visualization of the gastric varices will be performed after the EUS procedure to determine the effect of the obliteration of the feeder vessel by using a standard videoendoscope After the procedure patients will be observed for 2 hours in the recovery room before being discharged of the unit In cases of primary prophylaxis the treatment will be ambulatory
Finally a 1 3 9 and 12 months follow-up will be performed in order to confirm the results of the EUS-therapeutic by EUS and by upper endoscopy
Technical success will be considered as target of the vessels and deployment of the proposed EUS-therapeutic Treatment failure and early rebleeding will be considered when bleeding occurred the first five days and between 5 and 90 days respectively
Statistical analysis Demographic characteristics previous medication and radiological images will be described Quantitative variables will be described in mean or median and standard deviation or range as corresponding Qualitative variables will be described in percentages A Kolmogorov-Smirnov test with a p value 005 will be considered to be statistically significant The IECED institutional biostatistician will review statistical methodology of the study Statistical calculations will be performed in SPSS software suite v22
The aim of this study is to show the results and potential benefits by adding an angiography to the original EUS-guided injection of coils in combination with CYA technique to determinate and confirm the feeder vessel in GV treatment
MATERIALS AND METHODS
Study design It will be an interventional descriptive and prospective study performed in the Ecuadorian Institute of Digestive Disease IECED Omni Hospital Academic Tertiary Center Ecuador Patients have been included from July 2015 and will continue to be included up to October 2017 The study protocol and consent form has been approved by the institutional review board and will be conducted according to the declaration of Helsinki Written informed consent will be obtained from all subjects
Population selection inclusion and exclusion criteria Patients above 18 years old with gastric varices GV on the initial standard diagnostic upper endoscopy will be enrolled GV will be classified according to Sarin and Kumar classification Only gastro-esophageal varices type II GOV II fundal varices communicating with esophageal varices and isolated gastric varices type I IGV I fundal varices within a few centimeters of the gastric cardia will be included Gastro-esophageal varices type I GOV I will be excluded as they can be successfully treated by endoscopic band ligation Patients with active bleeding and history of previous bleeding due to GV secondary prophylaxis will be included as well as patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus The exclusion criteria will be pregnancy concurrent hepatorenal syndrome andor multi-organ failure platelet count less than 50000ml or International Normalized Rate INR 2 esophageal stricture splenic or portal vein thrombosis and allergy to iodine
Endoscopic Procedure and Technique All procedures will be performed in a hospital-based interventional endoscopy setting where radiology is available and by one endoscopist CRM under general anesthesia with tracheal intubation with the patient in supine position and using antibiotic prophylaxis EUS examination will be performed using a 38 mm working channel linear-array therapeutic echoendoscopes EG 3870UTK Pentax Hamburg Germany attached to an ultrasound console Avius Hitachi Tokyo Japan The echoendoscope will be positioned in the distal esophagus at the level of the cardia anterograde trans-esophageal transcrural approach to visualize the gastric fundus and intramural varices
Detection of the feeder vessel by EUS Once positioned water will be instilled to fill the gastric fundus in order to improve acoustic coupling and visualization of GV EUS color Doppler imaging will be used to allow direct visualization of the varices flow Following the gastric vessel and by using the fine-flow doppler color of the ultrasound console the vessel or vessels will be followed from the cardia distal part of the esophagus to the proximal part of the esophagus 2 to 3 cm above the cardia to detect the feeding vessel The feeding vessel is characterized by the convergence of all vessels Once the feeding vessel has been found a 19 gauge EUS-fine needle aspiration FNA Expect flexible Boston Scientific Marlborough USA will be used to access the vessel the stylet will be withdrawn and a 20 ml syringe with negative pressure will be used to evaluate blood return confirming intravascular location In order to prevent blood clotting of the needle tip 5 ml of saline solution will be instilled Moreover the flush with saline solution allows to confirm the flow of the gastric vessels under B-mode ultrasound visualization
Using angiography to confirm the target vessel feeder vessel and flow traject In the final diagnostic step an angiography will be performed using 5 to 10 mL of water-soluble contrast Ultravist Bayer Ecuador under fluoroscopic evaluation in order to ensure intravascular location and study varix flow direction afferent or efferent Angiography technical success will be measured determined as the possibility to define the flow trajectory vessel under fluoroscopy
EUS-guided deployment of Coils and Cyanoacrylate injection Finally patients will be treated by EUS-deployment of coils followed by CYA injection The intravascular embolization coils that will be used 10-16 mm coiled diameter 12-20 cm straight lengths 0035 inches diameter Nester Embolization Coil Cook Medical will be delivered into the vessel through the FNA needle using the stylet as a pusher Special attention will be paid not place the needle tip on the counter wall due to the risk of perforation bleed coil extrusion and to allow enough space for the coil to curl
The CYA that will be used is the 2-Octyl-CYA Dermabond Ethicon Piscataway NJ It will be injected always after the coils are deployed and then 1 mL of saline solution will be used to flush the glue completely through the needle The diameter 10-16 mm number of coils and the volume of the 2-Octyl-CYA injected will be calculated according to the diameter of the vessel measured on EUS and by the angiography of the vessel After 30 seconds once CYA has been solidified and the risk of bleeding on the puncturing site decrease the needle will be withdrawn Obliteration of the vessel will be confirmed 3 minutes later using Doppler imaging Complete obliteration of the treated varix will be defined as absence of Doppler flow on EUS
A direct visualization of the gastric varices will be performed after the EUS procedure to determine the effect of the obliteration of the feeder vessel by using a standard videoendoscope After the procedure patients will be observed for 2 hours in the recovery room before being discharged of the unit In cases of primary prophylaxis the treatment will be ambulatory
Finally a 1 3 9 and 12 months follow-up will be performed in order to confirm the results of the EUS-therapeutic by EUS and by upper endoscopy
Technical success will be considered as target of the vessels and deployment of the proposed EUS-therapeutic Treatment failure and early rebleeding will be considered when bleeding occurred the first five days and between 5 and 90 days respectively
Statistical analysis Demographic characteristics previous medication and radiological images will be described Quantitative variables will be described in mean or median and standard deviation or range as corresponding Qualitative variables will be described in percentages A Kolmogorov-Smirnov test with a p value 005 will be considered to be statistically significant The IECED institutional biostatistician will review statistical methodology of the study Statistical calculations will be performed in SPSS software suite v22
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None