Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760873
Status:
SUSPENDED
Last Update Posted:
2024-03-05
First Post:
2021-02-15
Brief Title:
Cryotherapy for GAVE
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Gastric Antral Vascular Ectasia Treatment With Balloon Cryotherapy A Multicenter Prospective Trial
Status:
SUSPENDED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Transferring trial to new institution and needs to be reviewedapproved before enrolling new participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAVE Cryo
Brief Summary:
Gastric antral vascular ectasia GAVE is a condition that can lead to blood loss in the gastrointestinal tract and low blood counts or anemia 12 GAVE is commonly associated with liver disease kidney disease and autoimmune immune problems but can also be seen in patients without those problems 2-4 It is common for GAVE to cause hospitalization of patients and significant blood transfusion requirements Given these problems effective treatment of GAVE is needed to reduce these potential problems
These treatments are performed by a gastroenterologist through a flexible endoscope most often with argon plasma coagulation APC5-7 APC is only partially successful at eradicating GAVE and often entails repeated endoscopic procedures Therapy with APC can also cause ulceration at times resulting in acute bleeding Cryoablation is an attractive alternative to APC as it should not cause increased blood loss and case reports suggest that ablation may be achieved with limited number of endoscopic sessions Prior problems with endoscopic cryotherapy include the high flow of gas and risk of perforation89 A recent retrospective investigation by this group has evaluated the first generation cryotherapy balloon demonstrating clinical safety and efficacy for GAVE10 A new balloon cryotherapy spray device was recently developed and does not require venting In this study we plan to prospectively evaluate the use of balloon cryotherapy to treat GAVE We predict that the therapeutic response of balloon cryotherapy will be greater than 80 effective at achieving clinical success or the loss of overt bleeding and need for packed red blood cell PRBC transfusion at 6 months after treatment
These treatments are performed by a gastroenterologist through a flexible endoscope most often with argon plasma coagulation APC5-7 APC is only partially successful at eradicating GAVE and often entails repeated endoscopic procedures Therapy with APC can also cause ulceration at times resulting in acute bleeding Cryoablation is an attractive alternative to APC as it should not cause increased blood loss and case reports suggest that ablation may be achieved with limited number of endoscopic sessions Prior problems with endoscopic cryotherapy include the high flow of gas and risk of perforation89 A recent retrospective investigation by this group has evaluated the first generation cryotherapy balloon demonstrating clinical safety and efficacy for GAVE10 A new balloon cryotherapy spray device was recently developed and does not require venting In this study we plan to prospectively evaluate the use of balloon cryotherapy to treat GAVE We predict that the therapeutic response of balloon cryotherapy will be greater than 80 effective at achieving clinical success or the loss of overt bleeding and need for packed red blood cell PRBC transfusion at 6 months after treatment
Detailed Description:
Gastric antral vascular ectasia GAVE classically termed watermelon stomach is a condition of chronic acute blood loss in the gastrointestinal GI tract and can lead to common utilization of packed red blood cell PRBC transfusion This condition occurs in 03 of endoscopic studies and 4 of studies performed for chronic or acute blood loss anemia12 GAVE is commonly associated with autoimmune disease in 60 of cases and chronic liver disease in 30 of cases2-4 Given the association with chronic liver disease GAVE can be mistaken for other GI pathologies such as portal hypertensive gastropathy PHG1112 Therefore identification of GAVE is important in the management of this condition
Historically there have been 1 series highlighting the use of a monopolar probe and heater probe to treat GAVE As these therapies have a low depth of thermal penetration these therapies are not commonly utilized for GAVE1314 The most commonly implemented endoscopic therapy is argon plasma coagulation APC Among the largest studies of APC the efficacy for treatment of GAVE is variable56 Additional outcomes include a reduction in the number of PRBC transfused in patients with GAVE that were treated with APC7 In addition to APC radiofrequency ablation RFA has also been evaluated in the setting of GAVE leading to a decrease in the transfusions needed during follow-up15 Similarly cryotherapy using a spray catheter has been evaluated for GAVE89 In these studies the patients did demonstrate endoscopic improvement lower transfusion requirements and normalization of their hemoglobin Despite these results the spray cryotherapy device requires the use of a venting tube to prevent complications and carries with it technical limitations that can make ablation difficult Our study group which includes University Hospitals Case Western Reserve Long Island Jewish Medical Center Geisinger Medical Center Columbia University Medical Center and The Cleveland Clinic Foundation of America This group has recently evaluated the first generation balloon cryotherapy device for GAVE demonstrating efficacy and safety10 Therefore in this study we set out to prospectively evaluate the efficacy of a new balloon cryotherapy device for the treatment of GAVE We predict that balloon cryotherapy will lead to greater than 80 clinical success need for PRBC transfusion and absent overt bleeding
Historically there have been 1 series highlighting the use of a monopolar probe and heater probe to treat GAVE As these therapies have a low depth of thermal penetration these therapies are not commonly utilized for GAVE1314 The most commonly implemented endoscopic therapy is argon plasma coagulation APC Among the largest studies of APC the efficacy for treatment of GAVE is variable56 Additional outcomes include a reduction in the number of PRBC transfused in patients with GAVE that were treated with APC7 In addition to APC radiofrequency ablation RFA has also been evaluated in the setting of GAVE leading to a decrease in the transfusions needed during follow-up15 Similarly cryotherapy using a spray catheter has been evaluated for GAVE89 In these studies the patients did demonstrate endoscopic improvement lower transfusion requirements and normalization of their hemoglobin Despite these results the spray cryotherapy device requires the use of a venting tube to prevent complications and carries with it technical limitations that can make ablation difficult Our study group which includes University Hospitals Case Western Reserve Long Island Jewish Medical Center Geisinger Medical Center Columbia University Medical Center and The Cleveland Clinic Foundation of America This group has recently evaluated the first generation balloon cryotherapy device for GAVE demonstrating efficacy and safety10 Therefore in this study we set out to prospectively evaluate the efficacy of a new balloon cryotherapy device for the treatment of GAVE We predict that balloon cryotherapy will lead to greater than 80 clinical success need for PRBC transfusion and absent overt bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None