HALO foredrag Endoskopi Sygeplejerskernes Årsmøde 2013

Hvordan går det med Barrets Patienter i Kongeriget Danmark

Study of 11.028 patients with BE

Patients• 11.028 Patients, entire Denmark

• Age 62,7 years (mean), 67% male

Follow-up• 67.105 patient-years (60.000 in all studies to date)

• 18 years (1992-2009)• Median follow-up 5,2 y

Hvid-Jensen et al, NEJM 2011; 365: 1375-83

Study of 11.028 patients with BE

Results11.028 BE patients

72 HGD

131 adenoc.

106 HGD 66 adenoc.

1st year

>1 year

Hvid-Jensen et al, NEJM 2011; 365: 1375-83

EAC in known BE patients

• 197 out of a total of 2602 EAC• 7.6 %

Hvid-Jensen et al, NEJM 2011; 365: 1375-83

Study of 11.028 patients with BE

Results11.028 BE patients

72 HGD

131 adenoc.

106 HGD 66 adenoc.

1st year

>1 yearRisk for adenocarcinoma

Risk for HGD1,2/1000 pyrs (95%CI:0,9-1,5) /0,12 % per year

1,9/1000 pyrs (95%CI:1,6-2,3)

Risk for adenocarcinoma or HGD2,6/1000 pyrs (95%CI:2,2-3,1)

2/3 within the first year !

Hvid-Jensen et al, NEJM 2011; 365: 1375-83

Study of 11.028 patients with BE

Are there High-risk subgroups ?

• Low Grade Dysplasi (LGD) 1st endoscopy (5%) : ”ever” LGD (8%):

• No LGD at 1st endoscopy (95%) 1,0/1000 pyrs (0,7-1,3)

5,1/1000 pyrs (3,0-8,6)5,5/1000 pyrs

(3,7-8,3)

Hvid-Jensen et al, NEJM 2011; 365: 1375-83

BarrxTM Flex Generator

20

BarrxTM RFA Catheters

Proximal

Distal

The following is a representation of the procedural steps used in prospective clinical trials for this device. This guide is not meant to replace physician judgment. Procedural steps may vary by patient according to patient tolerability, anatomy, motility, characteristics of the Barrett’s esophagus, and underlying health condition.

QUICK VIEW OF PROCEDURAL ASPECTS

1. Introduce endoscope, measure TIM/TGF, insert guidewire Flush with Mucomyst and suction out

2. Remove endoscope, leave GW in place Calibrate Sizing balloon

3. Introduce sizing balloon over GW 4. Start sizing 12 cm proximal to TGF, every 1 cm5. Remove sizing balloon, leave GW in place 6. Introduce HALO360+ ablation catheter over GW 7. Introduce endoscope along-side ablation catheter 8. Position proximal electrode edge 1-2 cm proximal to TIM 9. Ablate each 3 cm segment until overlapping TGF 10. Remove endoscope, catheter, and GW together (with direct

visualization) 11. Introduce endoscope and clean ablation zone 12. Inflate and clean ablation electrode (outside of body) 13. Re-Insert GW and remove endoscope, leave GW in place 14. Re-Introduce ablation catheter over GW 15. Repeat steps 7-1016. Remove both items, re-introduce scope and evacuate gastric

contents, inspect ablation zone

22

TGF

Quick Overview Circumferential Ablation

HALO 360

Courtesy of Charlie Lightdale, M.D., Columbia Presbyterian, New York

Focal RFA

Shaheen NJ, et al. N Engl J Med 2009

Complications

• Pain• Dysphagia• Bleeding• Fever• Vomiting

• Technical: Generel few problems – Captured HALO 90

Pain conclusions

• Bevare of the alcoholic patient• Pain is common, also after HALO 90• Be carefull with Barrettsegment longer 5-6 cm• Analgesic treatment?

KodeinmixtureWeak morfin - Tramadol

Dysphagia

Bleeding and fever

• 3 patients with bleeding 10. – 14. day postop.All 3 with antikoagulantia (2 Warfarin 1 asa)6 patients used antikoagulantiaComment: Use LMH 2-3 weeks after treatment before taking up Warfarin

4 patients with fever

GAVE Der er HALO godt men dyrt

Konklusion

• HALO er et godt værktøj til at abblation af fladeformet celleforandringer i specielt oesophagus.

• Giver nye behandlingsmuligheder af Barret’s Oesophagus. Specielt for de patienter med svære celleforandringer

• Det er forholdsvist nemt at bruge, men kræver dog en vis læringskurve

• Bagsiden at det er dyrt, og ikke uden komplikationer