Cryotherapy for GAVE

Bleeding Clinical Trial

— GAVE Cryo  

Official title:

Gastric Antral Vascular Ectasia Treatment With Balloon Cryotherapy: A Multicenter Prospective Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04760873
• Other study ID #: STUDY20181169
• Status: Suspended
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: August 12, 2024

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 1,2 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 (APC).5-7 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 perforation.8,9 A recent retrospective investigation by this group has evaluated the first generation cryotherapy balloon, demonstrating clinical safety and efficacy for GAVE.10 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.

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 0.3% of endoscopic studies and 4% of studies performed for chronic or acute blood loss anemia.1,2 GAVE is commonly associated with autoimmune disease in 60% of cases and chronic liver disease in 30% of cases.2-4 Given the association with chronic liver disease, GAVE can be mistaken for other GI pathologies such as portal hypertensive gastropathy (PHG).11,12 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 GAVE.13,14 The most commonly implemented endoscopic therapy is argon plasma coagulation (APC). Among the largest studies of APC, the efficacy for treatment of GAVE is variable5,6 Additional outcomes include a reduction in the number of PRBC transfused in patients with GAVE that were treated with APC.7 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-up.15 Similarly, cryotherapy using a spray catheter has been evaluated for GAVE.8,9 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 safety.10 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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 69
• Est. completion date: August 12, 2024
• Est. primary completion date: August 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Have GAVE

2. Have had treatment discussion with non-study team member (physician or GI advanced practice provider) of alternatives and have elected Cryotherapy

3. Patients with signs of GI bleeding defined as hemoglobin drop > 2 grams/dL, need for PRBC transfusion or overt bleeding (melena, hematemesis, hematochezia)

4. Patients undergoing EGD with Ablation for GAVE (treatment naïve, RFA, banding, APC failures)

5. Patients who underwent their last ablation at least 4 weeks prior

6. Platelet count > 40,000

7. International normalized ratio (INR) < 1.5

8. Age > 18 years and < 90 years

Exclusion Criteria:

1. Age < 18 years OR > 90 years

2. Inability to obtain consent

3. Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days

4. Platelet count < 40,000

5. INR > 1.5

Related Conditions & MeSH terms

• Bleeding
• Bleeding Gastric
• Gastric Antral Vascular Ectasia
• GAVE - Gastric Antral Vascular Ectasia
• Hemorrhage

Intervention

Device:
• cryotherapy
cryotherapy is a freeze spray that will be applied to GAVE for bleeding

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation of America	Cleveland	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Columbia University Medical Center-NYPH	New York	New York
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Columbia University, Geisinger Clinic, Long Island Jewish Medical Center, University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (18)

Cho S, Zanati S, Yong E, Cirocco M, Kandel G, Kortan P, May G, Marcon N. Endoscopic cryotherapy for the management of gastric antral vascular ectasia. Gastrointest Endosc. 2008 Nov;68(5):895-902. doi: 10.1016/j.gie.2008.03.1109. Epub 2008 Jul 21. — View Citation

Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available. — View Citation

Dulai GS, Jensen DM, Kovacs TO, Gralnek IM, Jutabha R. Endoscopic treatment outcomes in watermelon stomach patients with and without portal hypertension. Endoscopy. 2004 Jan;36(1):68-72. doi: 10.1055/s-2004-814112. — View Citation

Gross SA, Al-Haddad M, Gill KR, Schore AN, Wallace MB. Endoscopic mucosal ablation for the treatment of gastric antral vascular ectasia with the HALO90 system: a pilot study. Gastrointest Endosc. 2008 Feb;67(2):324-7. doi: 10.1016/j.gie.2007.09.020. — View Citation

Jabbari M, Cherry R, Lough JO, Daly DS, Kinnear DG, Goresky CA. Gastric antral vascular ectasia: the watermelon stomach. Gastroenterology. 1984 Nov;87(5):1165-70. — View Citation

Kantsevoy SV, Cruz-Correa MR, Vaughn CA, Jagannath SB, Pasricha PJ, Kalloo AN. Endoscopic cryotherapy for the treatment of bleeding mucosal vascular lesions of the GI tract: a pilot study. Gastrointest Endosc. 2003 Mar;57(3):403-6. doi: 10.1067/mge.2003.115. — View Citation

Lee FI, Costello F, Flanagan N, Vasudev KS. Diffuse antral vascular ectasia. Gastrointest Endosc. 1984 Apr;30(2):87-90. doi: 10.1016/s0016-5107(84)72326-1. No abstract available. — View Citation

Patel AA, Trindade AJ, Diehl DL, Khara HS, Lee TP, Lee C, Sethi A. Nitrous oxide cryotherapy ablation for refractory gastric antral vascular ectasia. United European Gastroenterol J. 2018 Oct;6(8):1155-1160. doi: 10.1177/2050640618783537. Epub 2018 Jun 12. — View Citation

Petrini JL Jr, Johnston JH. Heat probe treatment for antral vascular ectasia. Gastrointest Endosc. 1989 Jul-Aug;35(4):324-8. doi: 10.1016/s0016-5107(89)72802-9. — View Citation

Rey JF, Lambert R; ESGE Quality Assurance Committee. ESGE recommendations for quality control in gastrointestinal endoscopy: guidelines for image documentation in upper and lower GI endoscopy. Endoscopy. 2001 Oct;33(10):901-3. doi: 10.1055/s-2001-42537. No abstract available. — View Citation

RIDER JA, KLOTZ AP, KIRSNER JB. Gastritis with veno-capillary ectasia as a source of massive gastric hemorrhage. Gastroenterology. 1953 May;24(1):118-23. No abstract available. — View Citation

Roman S, Saurin JC, Dumortier J, Perreira A, Bernard G, Ponchon T. Tolerance and efficacy of argon plasma coagulation for controlling bleeding in patients with typical and atypical manifestations of watermelon stomach. Endoscopy. 2003 Dec;35(12):1024-8. doi: 10.1055/s-2003-44594. — View Citation

Scholvinck DW, Kunzli HT, Kestens C, Siersema PD, Vleggaar FP, Canto MI, Cosby H, Abrams JA, Lightdale CJ, Tejeda-Ramirez E, DeMeester SR, Greene CL, Jobe BA, Peters J, Bergman JJ, Weusten BL. Treatment of Barrett's esophagus with a novel focal cryoablation device: a safety and feasibility study. Endoscopy. 2015 Dec;47(12):1106-12. doi: 10.1055/s-0034-1392417. Epub 2015 Jul 9. — View Citation

Selinger CP, Ang YS. Gastric antral vascular ectasia (GAVE): an update on clinical presentation, pathophysiology and treatment. Digestion. 2008;77(2):131-7. doi: 10.1159/000124339. Epub 2008 Apr 4. — View Citation

Tobin RW, Hackman RC, Kimmey MB, Durtschi MB, Hayashi A, Malik R, McDonald MF, McDonald GB. Bleeding from gastric antral vascular ectasia in marrow transplant patients. Gastrointest Endosc. 1996 Sep;44(3):223-9. doi: 10.1016/s0016-5107(96)70155-4. — View Citation

Wahab PJ, Mulder CJ, den Hartog G, Thies JE. Argon plasma coagulation in flexible gastrointestinal endoscopy: pilot experiences. Endoscopy. 1997 Mar;29(3):176-81. doi: 10.1055/s-2007-1004159. — View Citation

Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22. — View Citation

Yusoff I, Brennan F, Ormonde D, Laurence B. Argon plasma coagulation for treatment of watermelon stomach. Endoscopy. 2002 May;34(5):407-10. doi: 10.1055/s-2002-25287. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	defined by the absence of PRBC transfusions and clinical evidence of bleeding	6 months
Secondary	Technical success	defined as the ability to treat > 75% of the endoscopic area	6 months
Secondary	Endoscopic success	defined as resolution of > 75% of the visible GAVE endoscopic surface	6 months
Secondary	Mean/total number of PRBC transfused	transfusion of packed red blood cells	6 months
Secondary	Change in hemoglobin	change in the lab test hemoglobin in grams/deciLiter	6 months
Secondary	Technical failure	defined as the need for additional ablative modalities to achieve the primary study outcome	6 months