Emorragia GE superiore: d lità t ti hmodalità emostatiche

endoscopiche a confrontoendoscopiche a confronto

E M iEnzo MasciDirettore UOC Endoscopia

Diagnostica e Chirurgia EndoscopicaDiagnostica e Chirurgia EndoscopicaIRCCS Istituto Nazionale dei Tumori

Milano

11

G.I. HEMORRHAGEG.I. HEMORRHAGE(Italy)

100 NEW CASES/YRS./100.000 INHABITANTS100.000 INHABITANTS

100‐120 HOSP. ADM. CASES/YRS./100 000 INHABITANTS100.000 INHABITANTS

68% > 60 yrs.MORTALITY   >70 a.  11.2%

< 60 a.    0.4%

DUAL THERAPY DUAL THERAPY vs. MONOTHERAPYvs. MONOTHERAPY

RECURRENT BLEEDINGRECURRENT BLEEDING NEED FOR SURGERYNEED FOR SURGERYRECURRENT BLEEDINGRECURRENT BLEEDING NEED FOR SURGERYNEED FOR SURGERY

R. Marmo A.J.G ‘07

NO CLEAR EVIDENCE THAT ANY NO CLEAR EVIDENCE THAT ANY TECHNIQUE IS SUPERIOR TOTECHNIQUE IS SUPERIOR TOTECHNIQUE IS SUPERIOR TO TECHNIQUE IS SUPERIOR TO INJECTION OF EPHINEPHRINE INJECTION OF EPHINEPHRINE ALONEALONE

COMBINED THERAPY IS THE COMBINED THERAPY IS THE TREATMENT OF CHOICE FORTREATMENT OF CHOICE FORTREATMENT OF CHOICE FOR TREATMENT OF CHOICE FOR HIGH RISK PATIENTS (Ia,Ib,IIa)HIGH RISK PATIENTS (Ia,Ib,IIa)HIGH RISK PATIENTS (Ia,Ib,IIa)HIGH RISK PATIENTS (Ia,Ib,IIa)

2 ENDOSCOPIC THERAPY2

• ASGE Guielinesno single modality superiorg y p

• UK Guidelineshemoclips partciculary useful for active bleeding largehemoclips partciculary useful for active bleeding large vessels

• NVU GI Bleeding Conference Canada• NVU GI Bleeding Conference Canada1) no single method is superior to the others2) the placement of clips is promising for high‐risk stigmata

44

55

Technical demanding cases3

• LARGE ULCER WITH PROTUBERANT VESSEL• POSTERIOR WALL IN DUODENUM• PROXIMAL LESSER CURVE IN STOMACH

• PATIENTS ON ANTITHROMBOTIC THERAPY

Pub Med

Animal TestingAnimal Testing

Treatment group H t ti

In a sterile Laparotomy Gastroepiploic vessels

Hemostatic Powder (n=5)

Control group Gastroepiploic vessels were dissected, inserted trough a gastrotomy,and freely exposed

Control group No Treatment (n=5)

and freely exposed in the gastric lumen, and the exposed vessel lacerated by needle knife

5 pigs “5 pigs “shamsham””vsvsvsvs

5 pigs Hemospray5 pigs Hemosprayp g p yp g p y

H2H2--blockers and Heparinblockers and Heparin

B. MangiavillanoB. Mangiavillano

Giday/Animal Study

C t l GControl Group •All animals died acutely (w/1 hour)

T t t GTreatment Group •All animals recovered for 7 days

No evidence of active bleeding in treatment group at day 7Mucosa appeared normal in all casesNo complications100% t h t i100% acute hemostasis

Necropsy in Hemospray Group•Healed gastrotomy•No foreign body granuloma in stomach and at injury sitej y•No evidence of emboli in lung or brain

Sung/PU Study

A t H t i 19/20 ti t ‡Acute Hemostasis:  19/20 patients ‡No Recurrent Bleeding:  17/19 patients †Procedural Adverse Events:  NoneDevice‐related SAE:  NoneMortality/SAE at 30‐day follow‐up:  None (20 

ti t )patients)

‡ Subsequently, 3 applications of hemostasis clips and 1 application of 8 mL adrenaline failed to maintain hemostasis. The patient was referred on for arterial embolization and was found to have a pseudoaneurysm.

† No active bleed was observed in two patients who had recurrent bleeding within 72 hours of the study procedure: the observation of recurrent bleeding was based upon clinical symptoms.clinical symptoms.

Peptic ulcer (Forrest 1 aPeptic ulcer (Forrest 1 a‐‐1 b)1 b)PROSPECTIVE SINGLEPROSPECTIVE SINGLE‐‐ARM PILOT ARM PILOT 

STUDYSTUDYSTUDYSTUDY

20 PatientsHemospray application within p y pp24 h of hospital ammission

(1‐2 application)(1‐2 application)Second look endoscopy at 72 h

Peptic ulcer (Forrest 1a Peptic ulcer (Forrest 1a ‐‐ 1b)1b)PROSPECTIVE SINGLEPROSPECTIVE SINGLE‐‐ARM PILOT ARM PILOT 

STUDYSTUDYSTUDYSTUDY

Exclusion criteriaExclusion criteriaExclusion criteriaExclusion criteria•• Hemodynamic instabilityHemodynamic instability

I d l hI d l h•• Incorrected coagulopathyIncorrected coagulopathy•• Use of FANS or antiplatelets agent, that could be not discontinuedUse of FANS or antiplatelets agent, that could be not discontinued

PPI b f dPPI b f d•• PPI before endoscopyPPI before endoscopy

Immediate Immediate hemostasishemostasis ::

95%95%95%95%

Hemostasis Hemostasis at 72hat 72h:: 89.5%89.5%

SEAL‐Clinical Outcomes6

Hemospray Monotherapy

Hemospray + Additional

Standard endoscopic

6

Monotherapy Additional endoscopic therapy

endoscopic therapy + Hemospray

Number of Patients

39 8 24

Rockall Score (median)

5.5 (range 3‐10)

7(range 5‐10)

6.5(range 5‐7)

Primary Haemostasis

38/39(97%)

6/8(75%)

16/24(67%)

Rebleed(7 days)

6/38(16%)

1/6(17%)

6/16(38%)

Mortality(7 days)

3/39(8%)

0 2/24(8%)

Peptic ulcer (Forrest 1a Peptic ulcer (Forrest 1a ‐‐ 1b)1b)PROSPECTIVE SINGLEPROSPECTIVE SINGLE‐‐ARM PILOT ARM PILOT 

STUDYSTUDYSTUDYSTUDYACUTE HEMOSTASIS 95% (19/20)ACUTE HEMOSTASIS 95% (19/20)ACUTE HEMOSTASIS 95%   (19/20)ACUTE HEMOSTASIS 95%   (19/20)1 Patient with pseudoaneurysm required arterial 1 Patient with pseudoaneurysm required arterial 

b li tib li tiembolizationembolizationRECURRENCE OF BLEEDING AT 72 hRECURRENCE OF BLEEDING AT 72 h2 Patients2 PatientsNO ADVERSE EVENT REPORTED AT 30 DAYS     NO ADVERSE EVENT REPORTED AT 30 DAYS     THELEPHONE CALLTHELEPHONE CALL

Duodenal Ulcer

SEAL Product Evaluation (71)

Survey to Evaluate the Application ofSurvey to Evaluate the Application of

Hemospray™ in the Luminal Tract

Objective: To gain clinical experience with Hemospray in Europe and Canadap y p

Gastroduodenal ulceration   58% (n=41)Tumours                                  7% (n=5)Oesophageal ulceration          4% (n=3)p g ( )Dieulafoy lesion                       4% (n=3)Post EMR                                3% (n=2)GAVE                                      3% (n=2)Other causes                        21%(n=15)

.

SEAL‐Ease of Application

90

60

70

80

40

50

60

rcen

t APCBipolar probe

20

30

40Pe

p pClipInjection

0

10

20

0

Comparable to Easier than More difficult No answer

SEAL‐Peptic ulcer outcomes

Hemospray Monotherapy

Hemospray + Additional

Standard endoscopicMonotherapy Additional 

endoscopic therapy

endoscopic therapy + Hemospray

Number of peptic ulcers

18(46%)

6(75%)

17(71%)(46%) (75%) (71%)

Proportion Forrest 1a

7/18(39%)

3/6(50%)

8/17(47%)Forrest 1a (39%) (50%) (47%)

Proportion Forrest 1b

9/18(50%)

3/6(50%)

8/17(47%)Forrest 1b (50%) (50%) (47%)

Unclassified ulcer 2/18 0 1/17(11%) (6%)

SEAL‐Clinical Outcomes6

Hemospray Monotherapy

Hemospray + Additional

Standard endoscopic

6

Monotherapy Additional endoscopic therapy

endoscopic therapy + Hemospray

Number of Patients

39 8 24

Rockall Score (median)

5.5 (range 3‐10)

7(range 5‐10)

6.5(range 5‐7)

Primary Haemostasis

38/39(97%)

6/8(75%)

16/24(67%)

Rebleed(7 days)

6/38(16%)

1/6(17%)

6/16(38%)

Mortality(7 days)

3/39(8%)

0 2/24(8%)

SEAL‐Rebleeding

Hemospray Monotherapy

Hemospray + Additional

Standard endoscopicMonotherapy Additional 

endoscopic therapy

endoscopic therapy + Hemospray

Total Rebleed 6 1 6

Forrest 1a Rebleed

3 0 2

F 1b 0 1 2Forrest 1b Rebleed

0 1 2

U l ifi d l 0 0 1Unclassified ulcer Rebleed

0 0 1

Non ulcer 3 0 1Non ulcer Rebleed

3 0 1

SEAL-Mortality

5 deathsLi di (2 i )Liver disease (2 patients)Myocardial infarction (1 patient)Aspiration pneumonia (1 patient)Perforation (1 patient)( p )

No deaths related to REBLEED

cancer-related upper GI bleeding 7

Early Clinical Evidence

7

Early Clinical Evidence

• Use of the endoscopically applied hemostatic d TC 325 i l d GIpowder TC‐325 in cancer‐related upper GI 

hemorrhage: preliminary experience

Conclusion: Hemospray, which was recently described in the management of nonmalignant upper GI hemorrhage, may become the method of choice in neoplastic bleeding given its noncontact application, malleable nature, and ability to cover large and multiple areas of bleeding

Principle Investigators:

ability to cover large and multiple areas of bleeding.

Yen‐I Chen, MD, Alan N. Barkun, MD, MSc, Constantine Soulellis, MD, Serge Mayrand, MD P Gh li MDMD, Peter Ghali, MD

Montreal, Quebec, Canada

88

Bleeding in Recurrence of Cancer

Prevention of Bleeding after EMR

Hemostatis was

16 unselected

Hemostatis was achieved in:5/8 pts. on ATT(63%)pts. with UGIB (63%)and 8/8 not on therapy(p=0,20)

CONTRAINDICATIONCONTRAINDICATION

in patients with suspicion of:in patients with suspicion of:

fi t l ( t i t ti l)fi t l ( t i t ti l)•• fistula (gastrointestinal)fistula (gastrointestinal)

•• perforationperforationpp

FutureFuture

9

OTSC for BLEDDING9

OTSC for  BLEDDING

99

Di l fDieulafoy

Autore

TITOLOSottotitolo

11

G.I. HEMORRHAGEG.I. HEMORRHAGE(Italy)

100 NEW CASES/YRS./100.000 INHABITANTS100.000 INHABITANTS

100‐120 HOSP. ADM. CASES/YRS./100 000 INHABITANTS100.000 INHABITANTS

68% > 60 yrs.MORTALITY   >70 a.  11.2%

< 60 a.    0.4%

2 ENDOSCOPIC THERAPY2

• ASGE Guielinesno single modality superiorg y p

• UK Guidelineshemoclips partciculary useful for active bleeding largehemoclips partciculary useful for active bleeding large vessels

• NVU GI Bleeding Conference Canada• NVU GI Bleeding Conference Canada1) no single method is superior to the others2) the placement of clips is promising for high‐risk stigmata

Technical demanding cases3

• LARGE ULCER WITH PROTUBERANT VESSEL• POSTERIOR WALL IN DUODENUM• PROXIMAL LESSER CURVE IN STOMACH

• PATIENTS ON ANTITHROMBOTIC THERAPY

44

55

SEAL‐Clinical Outcomes6

Hemospray Monotherapy

Hemospray + Additional

Standard endoscopic

6

Monotherapy Additional endoscopic therapy

endoscopic therapy + Hemospray

Number of Patients

39 8 24

Rockall Score (median)

5.5 (range 3‐10)

7(range 5‐10)

6.5(range 5‐7)

Primary Haemostasis

38/39(97%)

6/8(75%)

16/24(67%)

Rebleed(7 days)

6/38(16%)

1/6(17%)

6/16(38%)

Mortality(7 days)

3/39(8%)

0 2/24(8%)

cancer-related upper GI bleeding 7

Early Clinical Evidence

7

Early Clinical Evidence

• Use of the endoscopically applied hemostatic d TC 325 i l d GIpowder TC‐325 in cancer‐related upper GI 

hemorrhage: preliminary experience

Conclusion: Hemospray, which was recently described in the management of nonmalignant upper GI hemorrhage, may become the method of choice in neoplastic bleeding given its noncontact application, malleable nature, and ability to cover large and multiple areas of bleeding

Principle Investigators:

ability to cover large and multiple areas of bleeding.

Yen‐I Chen, MD, Alan N. Barkun, MD, MSc, Constantine Soulellis, MD, Serge Mayrand, MD P Gh li MDMD, Peter Ghali, MD

Montreal, Quebec, Canada

88

9

OTSC for BLEDDING9

OTSC for  BLEDDING

1010

hemospray.cookmedical.com

Difficult Duodenal UlcerDifficult Duodenal Ulcer