Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04222127
Status:
UNKNOWN
Last Update Posted:
2020-01-09
First Post:
2019-10-05
Brief Title:
EUS-guided Obturation of High Risk Gastric Varices Versus Standard Endoscopic Treatment
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
EUS-Guided Cyanoacrylate Injection Versus Standard Endoscopic Technique in the Obturation of High Risk Gastric Varices
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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:
Gastric varices occur in patients with portal hypertension mostly secondary to liver cirrhosis Although they bleed less frequently than oesophageal varices gastric variceal bleeding tends to be more severe with reported higher mortality
Endoscopic variceal obliteration EVO by direct endoscopic injection DEI using tissue adhesives like glue CYA or histoacryl demonstrated higher hemostasis and lower bleeding rates compared to band ligation or sclerotherapy Nevertheless CYA treatment is known to be associated with significant adverse events like para-variceal injection hemorrhage from post injection ulcer needle sticking in the varix intra-peritoneal injection leading to peritonitis and adherence of the glue to the endoscope fever embolization into the renal vein IVC pulmonary or systemic vessels
Endoscopic ultrasound EUS offers unique access to abdominal arterial and venous vasculature This has had the most clinical impact on the treatment of gastroesophageal varices where EUS may play a role both in the management and can deliver therapy in the form of glue injection endovascular coil placement or a combination of the two EUS enables an assessment using Doppler to confirm vessel obliteration after treatment However targeting the perforating feeder vessel rather than the varix lumen itself may theoretically minimize the amount of CYA needed to achieve obliteration of GVs and thereby reduce the risk of embolization
Endoscopic variceal obliteration EVO by direct endoscopic injection DEI using tissue adhesives like glue CYA or histoacryl demonstrated higher hemostasis and lower bleeding rates compared to band ligation or sclerotherapy Nevertheless CYA treatment is known to be associated with significant adverse events like para-variceal injection hemorrhage from post injection ulcer needle sticking in the varix intra-peritoneal injection leading to peritonitis and adherence of the glue to the endoscope fever embolization into the renal vein IVC pulmonary or systemic vessels
Endoscopic ultrasound EUS offers unique access to abdominal arterial and venous vasculature This has had the most clinical impact on the treatment of gastroesophageal varices where EUS may play a role both in the management and can deliver therapy in the form of glue injection endovascular coil placement or a combination of the two EUS enables an assessment using Doppler to confirm vessel obliteration after treatment However targeting the perforating feeder vessel rather than the varix lumen itself may theoretically minimize the amount of CYA needed to achieve obliteration of GVs and thereby reduce the risk of embolization
Detailed Description:
This is a single-centre pilot randomized trial study that includes 42 patients with gastric varices that will be classified according to the Sarin and Kumar classification into GOV II or IGV I with recently bleeding GV high-risk GV defined by Baveno VI consensus for primary prophylaxis
Eligible patients will be randomized in 2 groups using computer-generated random number sequences using excel software in concealed envelopes with block randomization design Group I will undergo EUS-guided CYA injection at entrance of perforator veins Group II will undergo DEI of CYA
Each patient will be subjected to
Written informed consent will be obtained from each patient including a discussion on the procedure
Clinical assessment including history taking and physical examination
Routine laboratory investigations including complete blood picture and serum creatinine
Liver function profile serum bilirubin AST ALT albumin and prothrombin time
The severity of underlying disease will be assessed by the Child-Turcotte-Pugh score CTP based on serum albumin bilirubin prothrombin time the presence of ascites and encephalopathy
All procedures will be performed under deep sedation or general anesthesia in the left lateral position
Intravenous antibiotics will be administered to all patients prior to the endoscopic procedure to minimize the risk of secondary bacterial infection Oral or intravenous antibiotics will be continued for at least 3 days following variceal injection
Endoscopic procedure and technique
Standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar Only high risk GOV II and IGV I varices 10 mm will be included
EUS examination will be done in all patients with a Pentax linear Echoendoscope EG3870UTK PENTAX medical Tokyo Japan attached to a Hitachi Avius ultrasound system Hitachi Medical Systems Tokyo Japan All EUS examinations will be done by two endosonographers The echoendoscope will be positioned in the distal esophagus at the level of the cardia to visualize the gastric fundus and intramural varices
EUS will be used to display the vascular anatomy in particular the feeding vein GVs will be classified endosonographically according to Boustière et al which considered size of GVs and gastric wall abnormalities
1 Size of GVs
Grade 0 none
Grade 1 small or non-confluent varies 5 mm
Grade 2 large or confluent varices 5 mm 2 Abnormalities of gastric wall
1 Grade 0 none
2 Grade 1 thickening and brilliance of the third hyperechogenic layer with or without fine internal anechogenic structures
3 Grade 2 visible vessels in the third layer which deform the entire wall with penetrating varices
EUS-guided injection of CYA will be done at entrance of of the varix or the perforator veins when identifiable using a mixture 11 of 2-octyl-cyanoacrylate lipidol using 19G EUS-FNA needle in Group I or DEI of CYA in Group II
Follow-up after endoscopy
After the procedure patients will be observed for 2 hours in the recovery room before being discharged Endoscopic examination and Doppler EUS will be repeated in all patients at 3 and 6 months post-procedure or sooner with recurrent bleeding to confirm eradication Hemostasis early post treatment bleeding and late post treatment bleeding will be recorded according to Baveno VI concensus
GVs will be considered obliterated by direct endoscopy when not visible andor hardened to catheter palpation Obliteration by Doppler EUS will be considered by visualization of clot and absence of Doppler flow within the gastric wall Repeat injection will be performed in the absence of obliteration Direct endoscopic and Doppler EUS examinations will be repeated again at 3 and 6 months after each injection
Eligible patients will be randomized in 2 groups using computer-generated random number sequences using excel software in concealed envelopes with block randomization design Group I will undergo EUS-guided CYA injection at entrance of perforator veins Group II will undergo DEI of CYA
Each patient will be subjected to
Written informed consent will be obtained from each patient including a discussion on the procedure
Clinical assessment including history taking and physical examination
Routine laboratory investigations including complete blood picture and serum creatinine
Liver function profile serum bilirubin AST ALT albumin and prothrombin time
The severity of underlying disease will be assessed by the Child-Turcotte-Pugh score CTP based on serum albumin bilirubin prothrombin time the presence of ascites and encephalopathy
All procedures will be performed under deep sedation or general anesthesia in the left lateral position
Intravenous antibiotics will be administered to all patients prior to the endoscopic procedure to minimize the risk of secondary bacterial infection Oral or intravenous antibiotics will be continued for at least 3 days following variceal injection
Endoscopic procedure and technique
Standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar Only high risk GOV II and IGV I varices 10 mm will be included
EUS examination will be done in all patients with a Pentax linear Echoendoscope EG3870UTK PENTAX medical Tokyo Japan attached to a Hitachi Avius ultrasound system Hitachi Medical Systems Tokyo Japan All EUS examinations will be done by two endosonographers The echoendoscope will be positioned in the distal esophagus at the level of the cardia to visualize the gastric fundus and intramural varices
EUS will be used to display the vascular anatomy in particular the feeding vein GVs will be classified endosonographically according to Boustière et al which considered size of GVs and gastric wall abnormalities
1 Size of GVs
Grade 0 none
Grade 1 small or non-confluent varies 5 mm
Grade 2 large or confluent varices 5 mm 2 Abnormalities of gastric wall
1 Grade 0 none
2 Grade 1 thickening and brilliance of the third hyperechogenic layer with or without fine internal anechogenic structures
3 Grade 2 visible vessels in the third layer which deform the entire wall with penetrating varices
EUS-guided injection of CYA will be done at entrance of of the varix or the perforator veins when identifiable using a mixture 11 of 2-octyl-cyanoacrylate lipidol using 19G EUS-FNA needle in Group I or DEI of CYA in Group II
Follow-up after endoscopy
After the procedure patients will be observed for 2 hours in the recovery room before being discharged Endoscopic examination and Doppler EUS will be repeated in all patients at 3 and 6 months post-procedure or sooner with recurrent bleeding to confirm eradication Hemostasis early post treatment bleeding and late post treatment bleeding will be recorded according to Baveno VI concensus
GVs will be considered obliterated by direct endoscopy when not visible andor hardened to catheter palpation Obliteration by Doppler EUS will be considered by visualization of clot and absence of Doppler flow within the gastric wall Repeat injection will be performed in the absence of obliteration Direct endoscopic and Doppler EUS examinations will be repeated again at 3 and 6 months after each injection
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