Cryotherapy for GAVE

NCT04760873 | Withdrawn DMC FDA Device

• 1 other identifier: MCC-21904
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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. 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.

Conditions

GAVE - Gastric Antral Vascular Ectasia; Bleeding; Bleeding Gastric

Keywords

GAVE; cryotherapy; bleeding; stomach; gastric; EGD; endoscopy

Outcome Measures

Primary Outcomes (1)

• Clinical success

  defined by the absence of PRBC transfusions and clinical evidence of bleeding

  6 months

Secondary Outcomes (5)

• Technical success

  6 months

• Endoscopic success

  6 months

• Mean/total number of PRBC transfused

  6 months

• Change in hemoglobin

  6 months

• Technical failure

  6 months

Study Arms (1)

Cryotherapy for GAVE

EXPERIMENTAL

Subjects will undergo cryotherapy for GAVE

Device: cryotherapy

Interventions

cryotherapy DEVICE

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

Cryotherapy for GAVE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have GAVE
• Have had treatment discussion with non-study team member (physician or GI advanced practice provider) of alternatives and have elected Cryotherapy
• Patients with signs of GI bleeding defined as hemoglobin drop \> 2 grams/dL, need for PRBC transfusion or overt bleeding (melena, hematemesis, hematochezia)
• Patients undergoing EGD with Ablation for GAVE (treatment naïve, RFA, banding, APC failures)
• Patients who underwent their last ablation at least 4 weeks prior
• Platelet count \> 40,000
• International normalized ratio (INR) \< 1.5
• Age \> 18 years and \< 90 years

You may not qualify if:

• Age \< 18 years OR \> 90 years
• Inability to obtain consent
• Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
• Platelet count \< 40,000
• INR \> 1.5

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Long Island Jewish Medical Center: collaborator
• Geisinger Clinic: collaborator
• Columbia University: collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (5)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Columbia University Medical Center-NYPH

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation of America

Cleveland, Ohio, 44195, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Related Publications (18)

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  PMID: 14722858 BACKGROUND

• 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.

  PMID: 6332757 BACKGROUND

• 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.

  PMID: 6714608 BACKGROUND

• 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.

  PMID: 8885337 BACKGROUND

• 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.

  PMID: 14648415 BACKGROUND

• 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.

  PMID: 11972274 BACKGROUND

• 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.

  PMID: 9201466 BACKGROUND

• 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.

  PMID: 12612530 BACKGROUND

• 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.

  PMID: 18640673 BACKGROUND

• 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.

  PMID: 30288277 BACKGROUND

• 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.

  PMID: 13052170 BACKGROUND

• 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.

  PMID: 18391491 BACKGROUND

• 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.

  PMID: 2788591 BACKGROUND

• 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.

  PMID: 18226696 BACKGROUND

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

  PMID: 24714327 BACKGROUND

• 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.

  PMID: 11605605 BACKGROUND

• 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.

  PMID: 26158241 BACKGROUND

• 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.

  PMID: 20189503 BACKGROUND

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia; Hemorrhage

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects with GAVE will undergo therapy with a cryotherapy device

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: October 14, 2020
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (5)