Interventional procedure overview of Balloon cryoablation for treating Barrett's oesophagus

Article

Number of people/follow-up

Direction of conclusions

Reasons for non-inclusion in table 2

Hamade N, Desai M, Thoguluva Chandrasekar V et al. (2019) Efficacy of cryotherapy as first line therapy in people with Barrett's neoplasia; a systematic review and pooled analysis. Diseases of the Esophagus, 32: 1-10

Systematic review and meta-analysis

N=6 studies (232 people)

There are scarce data on the use of cryotherapy as the primary modality for the treatment of BE

dysplasia. The published data demonstrate efficacy rates of 69% and 98% for complete eradication of metaplasia and neoplasia, respectively.

Only 1 cited paper for cryoballoon is included in table 2.

Visrodia K, Zakko L, Singh S et al. (2018) Cryotherapy for persistent Barrett's oesophague after radiofrequency ablation: a systematic review and meta-analysis. Journal of Gastrointestinal Endoscopy 87(6), 1396-1404

Systematic review and meta-analysis

N=11 studies; 148 people with BE treated with cryotherapy for persistent dysplasia or IM after RFA

2 studies on balloon cryotherapy; N=16 people.

Cryotherapy successfully achieved CE-D in 3 quarters and CE-IM in half of people with BE who did not response to initial RFA and adverse effects were reported in 6.7% of people.

There are only 2 studies on balloon cryotherapy included and they are both abstracts.

Westerveld DR, Nguyen K, Banerjee D et al. (2020) Safety and effectiveness of balloon cryoablation for treatment of Barrett's associated neoplasia: systematic review and meta-analysis. Endoscopy International Open, 18:E172-E178

Systematic review and meta-analysis

N=7 studies (272 people)

This meta-analysis suggests that balloon cryoablation is a safe and effective ablative technique for treatment of Barrett's oesophagus neoplasia; future prospective comparative trials are needed to corroborate these initial findings.

Of the 7 studies, 5 full-text articles are included in table 2 and 2 are abstracts.

Alzoubaidi D, Hussein M, Sehgal V et al. (2020) Cryoballoon ablation for treatment of people with refractory oesophageal neoplasia after first line endoscopic eradication therapy. Endoscopy International Open, 08:E891-E899

Case series

N=18 (median 71.5 years; 83% [15/18] male)

CR-D was achieved in 78% and CR-IM in 39% of people. There were no device malfunction or adverse events. Stenosis was noted in 11% of cases. At a median follow up of 19-months, CR-D was maintained in 72% of people and CR-IM in 33%.

This study includes a small sample.

John GK, Almario JAN, Skshintala VS et al (2017) Cryoballoon ablation for Barrett's oesophagus: A prospective single operator learning curve and time-efficiency study. Journal of Gastrointestinal Endoscopy 85(5S), AB566

Case series

N=74 BE people with 174 consecutive cryoablation procedures.

Device malfunction and balloon migration were associated with prolonged ablation time per site. The threshold number of procedures to overcome the learning curve was 18. After this threshold number was reached, the median ablation time per site reduced.

This is an abstract but contains complications associated with learning curve.

Louie BE, Hofstetter W, Triadafilopoulos G et al (2018) Evaluation of a novel cryoballoon swipe ablation system in bench, porcine, and human oesophagus models. Journal of Diseases of the Esophagus 31, 1-7

Case series

N=6 people (17% (1/6) female; and mean 68 years) treated with the cryoballoon swipe ablation system (CbSAS)

Six people tolerated the procedure without adverse events. CbSAS was simple to operate, and balloon contact with tissue was easily and uniformly maintained. The maximal effect on the mucosa is achieved with a 0.8 mm/second dose. The CbSAS device enables uniform 3 cm long, quarter-circumferential mucosal ablation in a one-step process by using a novel, through-the-scope balloon.

This is a pilot study with a small sample.

Schölvinck DW, Friedland S, Triadafilopoulos G et al (2017) Balloon-based oesophageal cryoablation with a novel focal ablation device: dose-finding and safety in porcine and human models. Diseases of the Esophagus 30, 1-8, DOI: 10.1093/dote/dox019

Case series

N=4 people with an area ≥2 cm of squamous epithelium or BE treated with CbFAS.

Direct postablation mucosal necrosis was observed; after 4 days necrosis and inflammation were limited to the submucosa. CbFAS cryoablation penetrates deeply into the oesophageal wall layers resulting in severe early ablation.

This study includes a small sample.

Spiceland CM, Joseph Elmunzer B, Paros S et al. (2019) Salvage cryotherapy in people undergoing endoscopic eradication therapy for complicated Barrett's oesophagus. Endoscopy International Open, 07: E904–E911

Case series

N=46 (6 balloon cryotherapy and 40 spray cryotherapy; mean 66 years; 91% [42/46] male)

Follow-up: 12 years

This study showed that cryotherapy appears effective

for salvage treatment of people with refractory dysplastic BE and IMC, successfully achieving CE-D and CE-IM in of 82.6% and 45.6% of people respectively. Higher-quality studies, ideally including randomized trials, are needed.

The clinical outcomes of the 6 people who received balloon cryotherapy are not separated from the overall results.

Trindade AJ and Canto MI (2019) Circumferential treatment of long-segment Barrett's oesophagus using the next-generation cryoballoon. Endoscopy, 51: E69-E70

Case report

N=1

This case demonstrates that the next generation cryoballoon ablation system enables successful treatment of wider and longer segments of Barrett's oesophagus. Studies are ongoing to determine optimal dosing strategies and technique.

This is a single case report.

Barrett M and Prat F (2018) Diagnosis and treatment of superficial oesophageal cancer. Annals of Gastroenterology, 31(3), 256-265, DOI: 10.20524/aog.2018.0252

Review

Balloon-based cryoablation of early squamous neoplasia has a high efficacy at 1 year and a good safety profile. This procedure has also been reported as an effective modality for ablating residual Barrett's islands after endoscopic resection.

The main cited papers for cryoballoon are all included in table 2.

Lal P and Thota PN (2018) Cryotherapy in the management of premalignant and malignant conditions of the oesophagus. World Journal of Gastroenyterology, 24(43), 4862-4869, DOI: 10.3748/wjg.v24.i43.4862

Review

Cryoballoon focal ablation using liquid nitrogen has been shown as an effective and a safe method for the treatment of BE with dysplasia and squamous cell carcinoma. Most common side effects include pain and oesophageal strictures.

The main cited papers for cryoballoon are all included in table 2.

Overwater A and Weusten BLAM (2017) Cryoablation in the management of Barrett's oesophagus. Current opinion in gastroenterology, 33(4), 261-269

Review

Cryotherapy using CbFAS is safe and well tolerated. The most common complaint is chest pain or discomfort. When compared with RFA, people treated with CbFAS reported less pain.

The main cited papers for cryoballoon are all included in table 2.

Parsi MA, Trindade AJ, Bhutani MS et al. (2017) Cryotherapy in gastrointestinal endoscopy. American Society for Gastrointestinal Endoscopy, 2(5), 89-95, DOI: 10.1016/j.vgie.2017.01.021

Review

Cryotherapy using nitrous oxide-inflated balloon has shown effective in conversing BE to neosquamous epithelium at a follow-up o f6 to 8 weeks, with minor pain being reported.

The main cited paper for cryoballoon is included in table 2.

Visrodia K, Zakko L and Wang KK (2018) Mucosal ablation in people with Barrett's oesophagus: fry or freeze? Digestive Diseases and Sciences, 63, 2129-2135, DOI: 10.1007/s10620-018-5064-x

Review

Cryoballoon therapy has shown effective in inducing CE-IM for people with (residual) BE islands.

The main cited papers for cryoballoon are all included in table 2.

Wang KK (2020) How I treat people with Barrett oesophagus when endoscopic ablation fails. Gastroenterology & Hepatology, 16(2): 82-87

Review

If initial ablation was started with radiofrequency ablation, switching to cryotherapy as an alternative

appears to be successful in most cases.

The mainly cited papers relating to balloon cryotherapy are included in table 2 or the appendix.

Künzli HT, Schölvinck DW, Meijer SL et al. (2017) Efficacy of the cryoballoon focal ablation system for the eradication of dysplastic Barrett's oesophague islands. Endoscopy, 49, 169-175, DOI: 10.1055/s-0042-120117

Case series

N=30 (14 LGD, 7 HGD, and 9 early adenocarcinoma) patients with 47 BE islands

Follow up: 56 days (Median)

Cryoablation of BE islands using the CryoBalloon is effective. BE islands were effectively targeted.

Deprioritized due to small sample size and short follow-up.

van Munster SN, Overwater A, Raicu MGM et al. (2019) A novel cryoballoon ablation system for eradication of dysplastic Barrett's oesophagus: a first-in-human feasibility study. Endoscopy, 52: 193-201

Case series

N=25 (13 in the dose-escalation phase and 12 in the confirmation phase)

Follow up: 8 weeks

CBA was feasible and effective for ablating larger BE areas.

Deprioritized due to small sample size and short follow-up.

Joana G, Demedts I and Bisschops R (2018) Treatment of low-grade dysplasia in Barrett's oesophagus with a new-generation cryoballoon device [abstract]. Endoscopy, 50, E318-E319

Case report

N=1

Follow-up: 3-month

At the 3-month follow-up,

complete regeneration of BE to neosquamous epithelium was observed. The treatment was

effective and was facilitated by the axial movement of the diffuser.

Deprioritized due to lack of reported outcomes, small sample and newer available evidence.

Tariq R, Enslin S, Hayat M, Kaul V. Efficacy of Cryotherapy as a Primary Endoscopic Ablation Modality for Dysplastic Barrett's Esophagus and Early Esophageal Neoplasia: A Systematic Review and Meta-Analysis. Cancer Control. 2020 Jan-Dec;27(1):1073274820976668.

SLR (subgroup analysis reporting on CBA)

N=1

CED and CE-IM rates are very comparable to the CE-D and CE-IM rates of RFA

Deprioritized as only 1 relevant study reported on CBA, included as a subgroup analysis. The included study (Canto 2018) was already included within this overview as a key study.