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VALIDATION OF A FRENCH TRAINING PROGRAM OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN LIVE PIGS AIMING TO START EFFICIENT AND SAFE HUMAN RECTAL ESD Jacques J. 1 , Legros R. 1 , Couquet CY. 2 , Valgueblasse V. 1 , Boulanger F. 3 , Le Sidaner A. 1 , Daloko R. 1 , Bouygues A. 1 , Carrier P. 1 , Debette-Gratien M. 1 , Loustaud-Ratti V. 1 and Sautereau D. 1 1 : Gastroenterology Unit, University Hospital, Limoges, France 2 : Research Lab, Limoges, Haute-vienne, France 3 : Department of Anesthesia, University Hospital, Limoges, France BACKGROUND ! ESD: complex procedure that allows higher rates of en bloc and complete resection for large precancerous lesions or superficial cancer ! Slow dissemination of ESD in Western countries: "Complexity of the procedure "Long procedure time "Flat learning curves "Lack of training ressources "Epidemiological differences with eastern countries that preclude the traditional mentor/apprentice formation ! We report the successful experience of a standardized local training program for ESD in a French tertiary center with a starting recruitment. . METHODS AND MATERIALS ! Prospective cohort, March 2013 to October 2013 ! In parallel: # 6 successive pigs: 31 gastric ESDs # 8 large rectal human ESDs (LSTs) ! Hybridknife type T (Erbe medical, Tübingen, Germany) adult silver standard gastroscope (Karl Stortz Endoscopy, Tuttlingen, Germany) ! Data prospectively recorded: duration of the procedure, size of the specimen, speed of the dissection, en bloc resection rate, complete resection rate • complications 1 Pig = 5 gastric ESDs Human rectal ESDs déc.-12 janv.-13 mars-13 mai-13 juin-13 août-13 oct.-13 nov.-13 janv.-14 RESULTS First Part : Pig gastric ESDs Gastric ESDs n=31 Monobloc 30/31=96,7% Size of the specimen (mm 2 ) 1072,8 Duration of the dissection (min) 47,9 Speed of dissection (mm2/min) 22,4 Bleeding rate 6/30=20% Perforation rate 1/30=3,3% 16,6 28,2 Variation of the speed of dissection (mm 2 / min) with training p<0,001 Second Part : Human rectal ESDs ( LSTs ) Human restal ESDs n=8 En bloc resection rate 8/8=100% Complete resection rate 8/8=100% Largest diameter (mm) 51,25 (+/- 10,4) Size of the specimen (mm 2 ) 2084,25 (+/- 863) Duration of the procedure 276,6 (+/- 101) Speed of dissection (mm 2 / min) 8,06 (+/- 2,9) Perforation rate 0% Per procedure bleeding rate 2/8=25% Post procedure bleeding rate 2/8=25% CONCLUSION and DISCUSSION - In Western countries not enough experts and case volumes to permit the traditional mentor/apprentice model to learn ESD - One or two « week-end worshops » formations are not enough to begin effective and safe ESD - One or two ESDs per month are needed to perform effective and safe ESD - Continous training with pig model in parallel with beginning ESD in human could represent a good alternative in a small tertiary center with starting recruitment - Probable safety of hybridknife for beginners !A LOCAL TRAINING PROGRAM WITH PIG MODEL ALLOWS STARTING HUMAN DISSECTION WITH HIGH SAFETY AND EFFICIENCY. ! INITIAL TRAINING ACCELERATES THE LEARNING CURVE AND THE CONTINUOUS PRACTICE IN PIG MODEL ALLOWS MAINTAINING CONSTANT TRAINING UNTIL THE RECRUITMENT OF PATIENTS BECOMES SUFFICIENT. ! NECESSITY TO ESTABLISH EUROPEAN CONTINUOUS TRAINING PROGRAM ON ESD? Draganov P. et al. Training for complex endoscopic procedures: how to incorporate endoscopic submucosal dissection skills in the West? Expert Rev Gastroenterol Hepatol. 2014 Feb;8(2):119–2 Deprez P, et al. Current practice with endoscopic submucosal dissection in Europe: position statement from a panel of experts. Endoscopy. 2010 Jul 9;42(10):853–8. 1. . No conflict of interest Copyright © 2014 JACQUES Jérémie MD, [email protected] 0 to 15 15 to 31

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Page 1: VALIDATION OF A FRENCH TRAINING PROGRAM OF … · VALIDATION OF A FRENCH TRAINING PROGRAM OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN LIVE PIGS AIMING TO START EFFICIENT AND SAFE

VALIDATION OF A FRENCH TRAINING PROGRAM OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN LIVE PIGS AIMING TO START

EFFICIENT AND SAFE HUMAN RECTAL ESD Jacques J.1, Legros R.1, Couquet CY.2, Valgueblasse V.1, Boulanger F.3, Le Sidaner A.1, Daloko R.1, Bouygues A.1, Carrier P.1, Debette-Gratien M.1, Loustaud-Ratti V.1 and Sautereau D.1

1 : Gastroenterology Unit, University Hospital, Limoges, France 2 : Research Lab, Limoges, Haute-vienne, France 3: Department of Anesthesia, University Hospital, Limoges, France

BACKGROUND

! ESD: complex procedure that allows higher rates of en bloc and complete resection for large precancerous lesions or superficial cancer

! Slow dissemination of ESD in Western countries: " Complexity of the procedure " Long procedure time " Flat learning curves " Lack of training ressources " Epidemiological differences with eastern countries that

preclude the traditional mentor/apprentice formation ! We report the successful experience of a standardized local

training program for ESD in a French tertiary center with a starting recruitment.

.

METHODS AND MATERIALS

! Prospective cohort, March 2013 to October 2013 ! In parallel:

#  6 successive pigs: 31 gastric ESDs #  8 large rectal human ESDs (LSTs)

! Hybridknife type T (Erbe medical, Tübingen, Germany) adult silver standard gastroscope (Karl Stortz Endoscopy, Tuttlingen, Germany)

! Data prospectively recorded: •  duration of the procedure, •  size of the specimen, •  speed of the dissection, •  en bloc resection rate, •  complete resection rate •  complications

1 Pig = 5 gastric ESDs

Human rectal ESDs

déc.-12 janv.-13 mars-13 mai-13 juin-13 août-13 oct.-13 nov.-13 janv.-14

RESULTS

First Part : Pig gastric ESDs Gastric ESDs n=31

Monobloc 30/31=96,7%

Size of the specimen (mm2) 1072,8

Duration of the dissection (min)

47,9

Speed of dissection (mm2/min) 22,4

Bleeding rate 6/30=20%

Perforation rate 1/30=3,3%

16,6

28,2

Variation of the speed of dissection (mm2/min) with training

p<0,001

Second Part : Human rectal ESDs (LSTs)

Human restal ESDs n=8

En bloc resection rate 8/8=100%

Complete resection rate 8/8=100%

Largest diameter (mm) 51,25 (+/- 10,4)

Size of the specimen (mm2) 2084,25 (+/- 863)

Duration of the procedure 276,6 (+/- 101)

Speed of dissection (mm2/min)

8,06 (+/- 2,9)

Perforation rate 0%

Per procedure bleeding rate

2/8=25%

Post procedure bleeding rate

2/8=25%

CONCLUSION and DISCUSSION - In Western countries not enough experts and case volumes to permit the traditional mentor/apprentice model to learn ESD -  One or two « week-end worshops » formations are not

enough to begin effective and safe ESD -  One or two ESDs per month are needed to perform effective

and safe ESD -  Continous training with pig model in parallel with beginning

ESD in human could represent a good alternative in a small tertiary center with starting recruitment

-  Probable safety of hybridknife for beginners

! A LOCAL TRAINING PROGRAM WITH PIG M O D E L A L L O W S S T A R T I N G H U M A N DISSECTION WITH HIGH SAFETY AND EFFICIENCY.

! INITIAL TRAINING ACCELERATES THE LEARNING CURVE AND THE CONTINUOUS P R A C T I C E I N P I G M O D E L A L L O W S MAINTAINING CONSTANT TRAINING UNTIL THE RECRUITMENT OF PATIENTS BECOMES SUFFICIENT.

! NECESSITY TO ESTABLISH EUROPEAN CONTINUOUS TRAINING PROGRAM ON ESD?!

Draganov P. et al. Training for complex endoscopic procedures: how to incorporate endoscopic submucosal dissection skills in the West? Expert Rev Gastroenterol Hepatol. 2014 Feb;8(2):119–2!Deprez P, et al. Current practice with endoscopic submucosal dissection in Europe: position statement from a panel of experts. Endoscopy. 2010 Jul 9;42(10):853–8. 1. .

No conflict of interest Copyright © 2014 JACQUES Jérémie MD, [email protected]

0 to 15 15 to 31