H. AKIN 1 ,*, E. SENATES 2, O. KOCAMAN 2 , A. DANALIOĞLU 2, A. T. INCE 2 , H. SENTÜRK 2

1 . M A R M A R A U N I V E R S I T Y I N S T I T U T E O F G A S T R O E N T E R O L O G Y , 2 . G A S T R O E N T E R O L O G Y D I V I S I O N , B E Z M I A L E M U N I V E R S I T Y ,

I S T A N B U L , T U R K E Y

PRECUT PAPILLOTOMY WITH THE ISO-TOME DEVICE IS AN ALTERNATIVE METHOD TO THE NEEDLE-KNIFE PRECUT PAPILLOTOMY TECHNIQUE IN ERCP CANNULATION

Introduction

ERCP cannulation failure rate is reported to be 5 to 15 % (*).

So-called 'difficult-to-cannulate' patients, In such cases, precut papillotomy/sphincterotomy (PCP) is often performed

The standard device for PCP is the classical Needle-Knife Papillotome (NKP).

*Cotton PB. Pre-cut papillotomy: a risky technique for experts only. Gastrointest Endosc 1989;35:578-9*Sriram PV, et al. The precut: when, where and how? A review. Endoscopy 2003;35: S24

Introduction

PCP by NKP is a blind procedure and complications may arise. It is associated with increased risks of; pancreatitis, bleeding, perforation, infections cardiovascular adverse events

Two factors that make the patients prone to complications are: The depth of cut may not be controlled. The beginning and direction of cut may not be optimal.

Introduction

Iso-Tome (ITP) (MTW Endoskopie, Wesel, Germany) is porcelain tipped wire papillotome intended to be used for submucosal dissection.

ITP’s previous semi-oval shaped tip form tried for PCP successfully might increase the success rate of cannulation

besides do not increase the complication rates (*)

* Park SH, Kim HJ, Park DH, et al. Pre-cut papillotomy with a new papillotome. Gastrointest Endosc 2005;62:588-591

Semi-oval Shaped Tip Iso-Tome Device

Iso-Tome Papillotomy

The main advantage of ITP is that when the porcelain tip is inserted, even partly, into the orifice, the cut can proceed safely.

After cutting the mucosa with ITP, the ampulla is exposed, further cuts are not blind and therefore theoretically safer.

New round tip form is more suitable for especially patients with small orifices

Round Shape Tip Iso-Tome Device

Aim

To test the efficacy and safety of new rounded tip form of ITP in comparison to classical NKP.

Materials and Methods

We selected the “difficult-to-cannulate” patients out of consecutive ERCP patients referred to our tertiary center between September 2011 and April 2012.

The studied patients were randomized into two arms: Classical Needle- knife Precut Papillotomy (NKP) or

Papillotomy with new rounded tip form of Iso-Tome (ITP).

Definitions

"Difficult-to-cannulate patients" were defined as the patients in whom cannulation fails in 10 minutes.

Criteria for ERCP Complications

*Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93

ERCP Settings

Duodenoscope: ED- 3680 TK 4.8, Corporation PENTAX Tokyo, Japan

Position of the patient: left lateral decubitus followed by prone position.

Sedation: Deep sedation by an anesthesiology team.

Electro surgery unit: ERBE VIO 300 D Unit (Germany) in 'Endo-Cut I mode' .

All PCP sessions were performed by a single experienced endoscopist (Hakan Senturk).

Exclusion Criteria

Unwilling to give informed consent,Presence of coagulopathy, Bulging papilla-If the papilla cannot be visualized because of anatomical distortions or malformations,

Complete tumoral invasion preventing to reach ampulla,

Intestinal obstruction.

Statistical Analysis

SPSS program (SPSS Inc., Chicago, IL, USA).

Fisher’s exact test or Student’s t-test whereever appropriate.

Statistically significant ‘p value’ is accepted as a two-tailed value of less than 0.05.

This study was approved by local ethics committee.

Written informed consent was obtained from each patient studied.

RESULTS

A total of 670 ERCP patients (391 female/ 279 male, mean age + SD, range: 58.2 ± 16.7, 17- 87).

139 difficult-to-cannulate patients (20.7 %) were randomized._

69 patients -ITP group (40 female/ 29 male, mean age + SD, 61.1 ± 16.0, range: 21-82)

70 patients -classical NKP group (40 female/ 30 male, mean age + SD, 60,1 ± 14.4, range:27-86)

RESULTS

CONCLUSION

For Pre-cut papillotomy, we did not find any difference between NKP and ITP in reference to efficacy and safety.