Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05038319
Status:
UNKNOWN
Last Update Posted:
2021-09-09
First Post:
2021-08-12
Brief Title:
SAFETY AND EFFICACY OF ENDOSCOPIC CONVENTIONAL CYANOACRYLATE GLUE VS EUS-GUIDED COIL PLUS CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES A RANDOMIZED CONTROLLED TRIAL
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
SAFETY AND EFFICACY OF ENDOSCOPIC CONVENTIONAL CYANOACRYLATE GLUE VS EUS-GUIDED COIL PLUS CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES
Status:
UNKNOWN
Status Verified Date:
2021-09
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:
GLUE
Brief Summary:
To compare safety and efficacy of Endoscopic conventional technique cyanoacrylate alone to the EUS-guided injection technique coil and cyanoacrylate in the treatment of gastric varices
Methods
Patient recruitment
Patients would be recruited from the endoscopy centre prior to their scheduled endoscopic intervention
Study intervention - Cyanoacrylate injection and EUS guided coil and glue injection The procedures would be performed by experienced endoscopists The procedure would be performed under conscious sedation or monitored anaesthesia The procedures would be performed by a therapeutic endoscope with the through the scope method The endoscope would be used to reach the site of Varices In Conventional technique treatment with cyanoacrylate the injection was performed using a 23-G sclerotherapy needle catheter InterjectCook One vial of N-butyl-2-cyanoacrylate 05 mL was mixed with Lipiodol in a 11 ratio and injected intravesically as a 1 mL bolus The injection was repeated until total hardening of the varix In treatment with coil and cyanoacrylate once the gastric varix was identified the total diameter of the vascular pseudotumor was measured and the puncture was made at the site of the widest varix The puncture was performed using a 19 G needle ExpectCook The size of the coil used was selected based on the size of the widest varix in the pseudotumor the size of the coil after release should not be greater than the caliber of the vessel Following coil deployment 2 mL of distilled water was injected followed by one vial 05 mL of N-butyl-2-cyanoacrylate mixed with Lipiodol in 11 ratio Then another 2 mL of distilled water was injected and the needle was removed
COIL and GLUE
Cyanoacrylate injection remains the conventional treatment method Since coils were first used to treat ectopic varices by Levy in 20086 this technique has been increasingly implemented into clinical practice However its higher cost has been a limiting factor in more widespread use
Depending on the ectasia of the varix the following coil was deployed 8 mm x 20 cm 10 mm x 20 cm or 10 mm x 30 cm Interlock-18 Fibered IDC Occlusion SystemCook
D25 Randomization Patients were randomized into two groups group I received standard endoscopic treatment with injection of a cyanoacrylateLipiodol 11 solution and group II received EUS-guided coiling and cyanoacrylate injection treatment A computer-based randomization list was generated with the online software Research Randomizer with 11 ratio wwwrandomizerorg An independent researcher not involved in this trial created the randomization list and sealed sequential opaque envelopes containing the random allocation sequence The complete list generation occurred before the first enrollment
D26 Post-procedural management After the procedure EUS with Doppler flow evaluation was repeated to check the presence or absence of flow within the varix The patients remained under observation in the GI endoscopy unit for at least one hour being released if no complaint was reported After endoscopic treatment all patients underwent thoracic and abdomen computerized tomography CT scanning within one week independent of the development of clinical symptoms
Methods
Patient recruitment
Patients would be recruited from the endoscopy centre prior to their scheduled endoscopic intervention
Study intervention - Cyanoacrylate injection and EUS guided coil and glue injection The procedures would be performed by experienced endoscopists The procedure would be performed under conscious sedation or monitored anaesthesia The procedures would be performed by a therapeutic endoscope with the through the scope method The endoscope would be used to reach the site of Varices In Conventional technique treatment with cyanoacrylate the injection was performed using a 23-G sclerotherapy needle catheter InterjectCook One vial of N-butyl-2-cyanoacrylate 05 mL was mixed with Lipiodol in a 11 ratio and injected intravesically as a 1 mL bolus The injection was repeated until total hardening of the varix In treatment with coil and cyanoacrylate once the gastric varix was identified the total diameter of the vascular pseudotumor was measured and the puncture was made at the site of the widest varix The puncture was performed using a 19 G needle ExpectCook The size of the coil used was selected based on the size of the widest varix in the pseudotumor the size of the coil after release should not be greater than the caliber of the vessel Following coil deployment 2 mL of distilled water was injected followed by one vial 05 mL of N-butyl-2-cyanoacrylate mixed with Lipiodol in 11 ratio Then another 2 mL of distilled water was injected and the needle was removed
COIL and GLUE
Cyanoacrylate injection remains the conventional treatment method Since coils were first used to treat ectopic varices by Levy in 20086 this technique has been increasingly implemented into clinical practice However its higher cost has been a limiting factor in more widespread use
Depending on the ectasia of the varix the following coil was deployed 8 mm x 20 cm 10 mm x 20 cm or 10 mm x 30 cm Interlock-18 Fibered IDC Occlusion SystemCook
D25 Randomization Patients were randomized into two groups group I received standard endoscopic treatment with injection of a cyanoacrylateLipiodol 11 solution and group II received EUS-guided coiling and cyanoacrylate injection treatment A computer-based randomization list was generated with the online software Research Randomizer with 11 ratio wwwrandomizerorg An independent researcher not involved in this trial created the randomization list and sealed sequential opaque envelopes containing the random allocation sequence The complete list generation occurred before the first enrollment
D26 Post-procedural management After the procedure EUS with Doppler flow evaluation was repeated to check the presence or absence of flow within the varix The patients remained under observation in the GI endoscopy unit for at least one hour being released if no complaint was reported After endoscopic treatment all patients underwent thoracic and abdomen computerized tomography CT scanning within one week independent of the development of clinical symptoms
Detailed Description:
All patients returned to the GI endoscopy unit approximately one month after initial endoscopic intervention for a repeat EUS evaluation
Technical success is defined as complete obliteration of varices and absence of flow signalOn this occasion if any residual flow was identified new treatment was performed following the same technique initially used and another evaluation was thus performed one month later This scenario was repeated until complete thrombosis was achieved
Complications that occurred during the procedure or within seven days post-intervention were defined as early complications whereas those that occurred greater than or equal to seven days post-intervention were defined as late complications
Recurrence was defined as evidence of any flow within the varix which occurred after initial obliteration had been confirmed
5Esophageal stricture 6Iodine allergy for EV
Follow-up
Once complete thrombosis was achieved follow-up evaluations were performed three and nine months later ie four and 10 months after therapy at which time patients were questioned about any post-procedure complications and underwent another EUS examination which permitted repeat evaluations of flow within the treated vessel
Technical success is defined as complete obliteration of varices and absence of flow signalOn this occasion if any residual flow was identified new treatment was performed following the same technique initially used and another evaluation was thus performed one month later This scenario was repeated until complete thrombosis was achieved
Complications that occurred during the procedure or within seven days post-intervention were defined as early complications whereas those that occurred greater than or equal to seven days post-intervention were defined as late complications
Recurrence was defined as evidence of any flow within the varix which occurred after initial obliteration had been confirmed
5Esophageal stricture 6Iodine allergy for EV
Follow-up
Once complete thrombosis was achieved follow-up evaluations were performed three and nine months later ie four and 10 months after therapy at which time patients were questioned about any post-procedure complications and underwent another EUS examination which permitted repeat evaluations of flow within the treated vessel
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