Introduction

The Cryoballoon Focal Ablation System (CbFAS) (Pentax Medical Inc) is an innovative device designed for the endoscopic ablation of Barrett's-related neoplasia. This system has been shown to provide advantages such as reduced stricture rates and improved patient tolerance compared to the conventional standard of care, radiofrequency ablation (RFA).
We report early outcomes from a prospective UK first multi-centre registry of consecutive patients who underwent Cryoablation for the endoscopic eradication (EET) of Barrett’s-related neoplasia.

Aims & Methods

Patients were prospectively enrolled from two tertiary referral centres for Barrett’s Oesophagus (BE). Inclusion criteria included patients with a BE segment no longer than 5cm with histologically-proven dysplasia on biopsy or endoscopic resection specimens suitable for EET of BE after MDT review. Cryoablation sessions were conducted at 3-month intervals until endoscopic eradication was complete. The standardised protocol involved administering 8 seconds per ablation for all enrolled patients with the CbFAS. Our primary outcome was complete eradication of BE. Secondary outcomes included the number of ablations performed, adverse events, device malfunction, stricture rate, patient tolerance, and endoscopist satisfaction which was evaluated using a 10-point Likert scale (1=poor, 10=excellent).

Results

Between January 2020 and December 2023, a total of 16 patients (35 treatment sessions) were treated. The median BE length was C0M2. Complete eradication of BE was achieved in 89% (8/9) of patients who had completed treatment. No instances of device malfunction or intraoperative adverse events were recorded. A stricture rate of 12.5% (2/16) was observed, both of which were successfully managed through endoscopic dilatation. All patients were recorded as tolerating the procedure well with sedation. The median endoscopist satisfaction score was 9 (+/- 2.4) with only one recorded instance of difficulty attributed to balloon positioning.

Conclusion

These preliminary results from the UK cryoablation registry suggest that cryoablation with the CbFAS is a safe and effective therapy for BE-related dysplasia. The stricture rate appears to be comparable to that observed with RFA and similar studies. With the planned enrolment of further centres and suitable patients, this registry will further enhance our understanding of the long-term efficacy and safety profile of cryoablation using the CbFAS.

Introduction

The Cryoballoon Focal Ablation (CbFA) (C2 Pentax Medical) system offers an endoscopic treatment option for Barrett's-related dysplasia (BE-D). CbFA has been shown in clinical studies to be a highly effective and well tolerated intervention for BE-D. We report the largest real-world prospective multi-centre registry of consecutive patients who underwent treatment with CbFA for the endoscopic eradication (EET) of BE-D.

Aims & Methods

Patients were prospectively enrolled from three tertiary referral centres for Barrett’s esophagus (BE). Inclusion criteria included patients with a BE segment of C≤2M≤5 with histologically-proven dysplasia or intramucosal adenocarcinoma on biopsy or at endoscopic resection. CbFA sessions were conducted at 3-monthly intervals until EET was complete (Max 5 sessions). Follow up biopsies were taken to confirm eradication of dysplasia and intestinal metaplasia. The primary outcome was the complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D). Secondary outcomes included the number of ablations performed, adverse events, device malfunction, stricture rate, endoscopist satisfaction score (Likert scale: 1=poor, 10=excellent) and balloon positioning complexity (Likert scale: 1=easy positioning, 5=difficult positioning).

Results

Between January 2020 and December 2024, thirty-eight patients (79%: male, mean age: 69) were treated with CbFA (81 treatment sessions). The median BE length was C0M2. 84% (n=32) were treatment naïve with the 16% (n=6) being RFA refractory BE. 55% (n=21) had undergone endoscopic resection prior to entry (3=endoscopic submucosal dissection:18=endoscopic mucosal resection). Patient characteristics according to baseline histology is highlighted in table 1.
CE-D was achieved in 100% (12/12) and CE-IM in 83% (10/12) of patients who had completed treatment. The median number of treatment sessions for those completing treatment was 2.5 (SD=1.4). No new neoplastic lesions were detected during treatment.

Table 1: Patient characteristics according to baseline histopathology
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No device malfunction or intraoperative adverse events were recorded. Stricture formation post CbFA requiring dilatation was observed in 8% (n=3) of cases.
The median endoscopist satisfaction score was 9 (SD=1.8) with 3 cases recorded as difficult due to balloon positioning. The median ballon positioning complexity score was 2 (SD=1.5).

Conclusion

These results from the UK cryoablation registry suggest that CbFA is a safe and effective treatment for BE-D and mirror findings from larger controlled studies. With the planned enrolment of further centres, this registry will further enhance our understanding of the long-term efficacy and safety profile CbFA.

Introduction

Transmural oesophageal defects are associated with significant morbidity and mortality. Repeat surgery is often complicated and undesirable with variable outcomes. Increasingly, endoscopic interventions including clip closure devices, temporary full covered self-expanding metal stents (FcSEMS) and endoscopic suturing are being used to treat this problem. Endoscopic vacuum therapy (EVT) relies on a sponge-based device that is placed either within a cavity or the oesophageal lumen to provide continuous negative pressure over the defect which enhances drainage and tissue micro-perfusion.
The VacStent GI^TM (MicroTech) device is an innovative endoscopic solution which synergistically incorporates the advantages of a fcSEMS while synchronously employing the principles of EVT.

Aims & Methods

We retrospectively analysed patients undergoing treatment for transmural oesophageal defects with the VacStent GI^TM (MicroTech) device between October 2023 and Febuary 2025 at two upper GI surgical centres (UCLH and University Hospitals of Derby).
All patients had cross-sectional imaging and any chest contamination was drained before stent insertion. Defects involving the cricopharnyx and/or those more than 5cm were excluded. Continuous negative pressure of 125 mmHg was used for the first 24 hours after stent placement and then reduced to 75 mmHg. The VacStent was exchanged every 7-10 days until defect closure. All cases were performed in endoscopy with a minimum of propofol sedation and were discussed as part of specialist MDT.
The primary outcome was clinical success, defined as the endoscopic and radiological evidence of defect closure. Secondary outcomes included technical success, number of stent exchanges, serious adverse device effect (SADE) and time to defect closure.

Results

The VacStent GI^TM (MicroTech) device was used 33 times in 16 patients with a median age of 65 years (IQR 57-75). The study population comprised 75% male and 25% females. 2/16 (12.5%) had defects secondary to boerhaaves syndrome, 4/16 (25%) had iatrogenic defects and, 10/16 (62.5%) had anastomotic leaks (1=benign:9=malignant).
Clinical success was achieved in 10/16 (62.5%) patients with a technical success rate of 100%. Median time to defect closure following index VacStent implantation was 10 days (IQR 6-15) with a median of 1 VacStent exchange (IQR 0-2). The median defect size was 10mm (IQR 6-14). Cases of VacStent failure appear to be related to defects more than 4cm and those within a conduit (Table 1). There was a single adverse event related to severe bleeding due to the stent becoming embedded to the oesophageal lumen – after the VACStent was removed, a temporary fully covered stent was placed to tamponade any bleeding and later removed uneventfully.

Conclusion

In conclusion, our experience has demonstrated that VacStent is a safe and effective treatment option for oesophageal defect closure achieving this in 62.5% of patients. This is a challenging cohort of patients that usually have limited treatment options. Multi-disciplinary collaboration and early recognition of both appropriate and inappropriate defect dimensions and aetiology is critical to enhancing success rates. Ongoing experience with a more diverse and larger patient population will further clarify the position of the VacStent device in the EVT treatment paradigm.

Introduction

A decade ago, endoscopic surveillance (ES) for Barrett’s oesophagus (BO) was recommended to improve the outcome of oesophageal adenocarcinoma through early recognition and prevention¹. The yield of ES to detect dysplasia may depend on guideline adherence and quality of endoscopy^2,3,4.

Aims & Methods

The aim is to assess whether dedicated (expert) ES (DS) is more effective than conventional (non-dedicated) ES (NS) by means of Key Performance Indicators (KPI), Dysplasia Detection Rate (DDR), use of advanced imaging and complication rate.
This multicentre (5 UK hospitals) retrospective study includes real-world ES data from 1303 procedures conducted within the last 8 years. The endoscopy and histology reports and clinical notes of consecutive procedures were accessed. The data were collected in spreadsheets and then analysed with SPSS-23. Two services were reported demographically and compared with appropriate statistical tests and logistic regression to test factors associated with DDR.

Results

Data from 680 DS and 623 NS procedures were included, comprising 906 (69.5%) males and 397 (30.5%) females (M:F=2.3:1.0). The age ranged from 14-90 yrs with a mean of 63.7 (SD±12.5) yrs. The maximum length of the BO was 18 cm with a mean of 4.1 cm (SD±3.0). There were significant differences in all the KPIs (Prague classification, Barrett’s island description, hiatus hernia delineation, visible lesion documentation, Paris classification, Seattle protocol adherence and inspection time) favoring the DS (P<0.001). Other comparisons: narrow band imaging (NBI, P<0.001), acetic acid chromoendoscopy (AAC, P<0.001), sedation (P=0.02) and acquisition of target biopsies (, P<0.001) were also significantly higher in DS while the complication rate was significantly lower (P=0.05). Importantly, the DDR was significantly higher in DS (58/680 (8.5%)) than in NS (16/623 (2.6%)) with a P<0.001. Regression analysis showed: increasing age, male sex, lesion description and Paris classification documentation were associated with higher DDR (Table 1), while other indicators showed no significant association.

Table 1. Factors associated with dysplasia detection

	Odds ratio	95% CI	P
Age	1.03	1.01 – 1.05	0.002
Sex	1.86	1.16 – 2.98	0.009
Visible lesion documentation	2.23	1.03 – 4.81	0.041
Paris classification	2.19	1.00 – 4.77	0.049

Conclusion

Surveillance for BO through a dedicated service with high quality endoscopy can produce a higher diagnostic yield with improved DDR and a lower complication rate. Given these benefits, large-scale prospective studies are warranted to assess the true impact on mortality, morbidity, cost benefit and patient-reported outcomes, ensuring that surveillance service provides a meaningful clinical benefit, particularly with risk stratification concerning the factors associated with disease progression.

References

1. Fitzgerald et al. (2013). BSG guidelines on Barrett’s oesophagus. Gut, 63(1), 7–42. doi:10.1136/gutjnl-2013-305372.
2. Britton et al. (2019). Improving accuracy in Barrett’s surveillance. Frontline Gastroenterol, 10(2), 128–134. doi:10.1136/flgastro-2018-101019.
3. Ratcliffe et al. (2023). Surveillance service improves dysplasia detection. Frontline Gastroenterol, 15(1), 21–27. doi:10.1136/flgastro-2023-102425.
4. Ratcliffe et al. (2023). Dedicated Barrett’s surveillance vs. standard care. iGIE, 3(1), 58–65. doi:10.1016/j.igie.2023.11.003.

Introduction

Focal cryoballoon ablation (FCBA) is a relatively new ablation modality for the treatment of Barrett’s esophagus (BE) related neoplasia. This prospective, European multicenter study (Euro-Coldplay, NTR NL7253) aimed to evaluate the efficacy and safety of FCBA for the treatment of limited BE.

Aims & Methods

In eight European Barrett referral centers, patients with C≤2M≤5 BE with an indication for ablation therapy were eligible for inclusion. Before entry, any visible lesion had to be removed by endoscopic resection (max. 2cm in length and 50% of circumference). FCBA was performed by experienced and trained endoscopists at 3 month intervals until complete endoscopic eradication of BE (max. 5 sessions). During every session, the esophagogastric junction was treated circumferentially followed by all visible BE using side-by-side ablations with a dose of 8 seconds per ablation. After at least two FCBA sessions, add-on treatment was allowed with either argon plasma coagulation (APC) for BE lesions of <5mm (max. 2 sessions) or a single endoscopic mucosal resection for lesions of >5mm. Outcomes included complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D), and adverse event rate.

Results

107 patients (91 males; mean age 65) with a median BE length of C0M2 were included, containing low-grade dysplasia (32%), high-grade dysplasia (32%) or early cancer (39%) as worst baseline histology. Currently, 5/107 patients are still under treatment and therefore excluded from further analysis. Of the remaining patients, 97 (97/102; 95%) patients have finished the treatment phase per protocol, while four (4/102; 4%) patients left the study prematurely. Only one (1/102; 1%) patient could not be treated with FCBA due to a device malfunction requiring a switch to radiofrequency ablation. Overall, 65/102 (64%) patients underwent endoscopic resection at entry followed by a median of 2 (IQR 2-2) FCBA treatments with a median of 7 (IQR 5-9) ablations per treatment session. During the treatment phase, 3/102 (3%) patients developed a new visible, neoplastic lesion amenable for endoscopic resection (high-grade dysplasia n = 2, low-risk T1 cancer n = 1). Add-on treatment after at least two FCBA sessions was performed in 38/102 (37%) patients, of whom the most were treated with APC for small remaining Barrett islands (37/38; 97%). CE-D was achieved in 95% (97/102) and CE-IM in 91% (93/102), per intention-to-treat analysis. Per-protocol analysis, CE-D and CE-IM were achieved in 100% (97/97) and 96% (93/97), respectively. Esophageal stricture was the most common adverse event in 13/102 (13%) patients, which resolved after a median of 2 (IQR 1-4) dilations. Only three (3/102; 3%) patients suffered a severe stricture requiring >3 dilations. No perforation or bleeding were observed, while buried BE glands were seen in 1/102 (1%).

Conclusion

In expert hands, endoscopic eradication therapy with FCBA seems to be highly effective with an acceptable safety profile for patients with limited BE. Long-term follow-up is warranted to evaluate the durability of the treatment response.

Disclosure

C.N. Frederiks have received speaker's fee and reimbursement of study-related travel costs from Pentax Medical. A. Overwater has received reimbursement of study-related travel costs from Pentax Medical. J.J.G.H.M. Bergman is a consultant for Medtronic, Cook Medical, and Boston Scientific, and has received research funding from Pentax Medical, C2 Therapeutics, Medtronic, Aqua Medical, Olympus Endoscopy, and Fuji-film. R.E. Pouw is a consultant for MicroTech, and has received speaker’s fee from Medtronic. R. Bisschops is a consultant for Pentax Medical, Medtronic, and Erbe Medical, and has received research funding and speaker’s fees from Pentax Medical, Medtronic, and Erbe Medical. T. Beyna is consultant for Medtronic, Erbe Medical, Microtech Endoscopy, Olympus Endoscopy, and Boston Scientific. B.L.A.M. Weusten has received research funding from Pentax Medical, C2 Therapeutics, and Aqua Medical. The remaining authors declare to have no disclosures relevant to this manuscript.

Introduction

Malignant oesophageal strictures can cause airway compromise and fistula formation¹. Combined oesophageal and airway stenting is a potential treatment yet no guidelines exist². This study aims to describe the outcomes of same-session oesophageal and airway endoscopic stenting for malignant strictures and propose an algorithm for intervention.

Aims & Methods

A retrospective study on patients undergoing same-session gastroenterology (GI) and respiratory endoscopy at University College London Hospital, 2019-2023. All procedures were with anaesthetic-led propofol sedation. Endoscopic decision making was based on preprocedure multidisciplinary team meeting (MDM) and intra-procedure clinical assessment. Data collected included malignancy type, luminal narrowing, complications, and mortality.

Results

26 patients were identified. Mean age was 63 years. Cancer type was oesophageal (81%) or lung (19%). The most common referral indication was dysphagia (42%); airway compromise was often seen on imaging (65%). Stent insertion was oesophageal only (35%), airway only (19%) and dual (27%) (Table 1). Airway stenting was common (80%) if airway stenosis was >50%. No airway stenting occurred if stenosis was <50%. After oesophageal stenting, repeat bronchoscopy showed increased airway stenosis in 4 patients (25%). The only intraoperative complication was one oesophageal perforation. New tracheooesophageal fistula was the most common post-intervention complication (15%). Median time from malignancy diagnosis to death was 7.9 weeks.

Table 1: Procedure and intervention details for same-session procedures
Characteristic	Dual Intervention (N=7)	Oesophageal Intervention alone (N=9)	Airway Intervention alone (N=5)	No Intervention (N=5)
Procedure time, mins	87 (66, 152)	41 (36, 43)	64 (55, 66)	39 (28, 86)
Procedural Airway None Endotracheal tube Rigid Bronchoscopy	6 (86) 0 1 (14)	8 (89) 1 (11) 0	3 (60) 1 (20) 1 (20)	3 (60) 0 2 (40)
Fistula at endoscopy	4 (57)	3 (33)	3 (60)	2 (40)
Oesophageal narrowing: <50% >50% Not reported	1 (14) 5 (71) 1 (14)	3 (33) 5 (56) 1 (11)	2 (40) 2 (40) 1 (20)	0 4 (80) 1 (20)
Airway narrowing: 0-25% 25-50% 50-75% 75-100%	0 0 1 (14) 6 (86)	7 (78) 2 (22) 0 0	0 0 0 5 (100)	1 (20) 1 (20) 0 3 (60)†
Location of airway narrowing: Not documented Trachea Left main/lower lobe Right main/lower lobe Multiple locations	0 3 (43) 3 (43) 0 1 (14)	3 (33) 4 (44) 1 (11) 1 (11) 0	0 0 3 1 1	0 1 (20) 2 (40) 0 2 (40)
Type of airway stent: Self-expanding metal Silicone stent*	6 (86) 1 (14)	0 0	4 (80) 1 (20)	0 0
Post Procedure Complications: Oesophago-airway fistula Airway stent migration Airway stent obstruction Significant bleeding Respiratory failure Repeat procedure	1 (14) 0 1 (14) 0 1 (20) 3 (43)	1 (11) 3 (33) 0 0 0 7 (78)	2 (40) 0 1 (20) 0 1 (20) 1 (20)	0 0 0 0 0 2 (40)

Data is presented as N (%) or median (IQR). *Silicone stent includes the placement of one straight bronchial stent and one tracheal Y-stent. ^†two of three patients with no intervention despite significant airway stenosis had multiple locations of airway involvement and stent placement was not feasible.

Conclusion

We present the first algorithm (Figure 1) for endoscopic stenting in patients with malignant oesophageal stricture and airway involvement. We suggest upper GI and respiratory MDM to plan same-session endoscopy with decision-making framed by patient-centred goals given their poor prognosis.

References

1. Khan A, Hashim Z, Neyaz Z, Agarwal A, Mohindra S, Nath A. Dual Airway and Esophageal Stenting in Advanced Esophageal Cancer With Lesions Near Carina. J Bronchology Interv Pulmonol.2020;27(4):286-293. doi:10.1097/LBR.0000000000000672
2. Bi Y, Ren J, Chen H, Bai L, Han X, Wu G. Combined airway and esophageal stents implantation formalignant tracheobronchial and esophageal disease. Medicine. 2019;98(3):e14169.doi:10.1097/MD.0000000000014169