Tringali A. La CPRE. ASMaD 2016

ENDOSCOPIA DIGESTIVA CHIRURGICA
UNIVERSITA’ CATTOLICA DEL SACRO CUORE
EUROPEAN ENDOSCOPY TRAINING CENTRE
ANDREA TRINGALI
E n d o s c o p i a D i g e s t i v a C h i r u r g i c a
U n i v e r s i ta ’ C a t t o l i c a d e l S a c r o C u o re
Fondazione Policlinico Gemelli – Roma
E u r o p e a n E n d o s c o p y Tr a i n i n g C e n t e r
La CPRE

CPRE: Colangio Pancreatografia Retrograda Endoscopica

ERCP: therapeutic procedure, why?
MRCP: diagnostic exam

EUS
diagnostic procedure

Complications !!!
Acute Pancreatitis
overall incidence 1%-7%, severe pancreatitis 0.4%, mortality <0.1%
Post-Sphincterotomy Bleeding
incidence 1%-2% up to 10%, severe 0.5%, mortality 0.1%
Acute Cholangitis
incidence ≈ 1%, severe 0.1%, mortality <0.1%
Acute Cholecystitis
incidence 0.2-0.5%, severe 0.1%, mortality <0.1%
Perforations
incidence 0.3%-0.6%, severe 0.2%, mortality <0.1%

Clinical history + Lab tests + imaging
ERCP. Indications! Indications! Indications!
P.B. Cotton, GIE 2006 54%

ERCP: therapeutic procedure, when?
Benign biliary diseases
Stones
Benign biliary strictures and leaks
Benign pancreatic diseases
Chronic pancreatitis (stones and stricrures)
Acute recurrent pancreatitis
Post-surgical and post-traumatic pancreatic leak
Malignant biliary strictures
Palliation
Pre-operative drainage

ERCP: stones extraction
Fogarty balloon Dormia basket

Biliary stones: case 1
R.D. 48 years old lady
 Symptomatic gallstone disease since 1 month (no fever)
 US (2 weeks before admission):
multiple gallstones (3-4 mm), non dilated bile ducts
 Admitted for elective cholecystectomy
 Bilirubin NormalALT 153 U/l (x 3)
ALP 1248 U/l (x 4) GGT 1015 (x 16)
 Therapy with antidepressant

WHAT TO DO?
 Cholecystectomy
 Repeat LFTs
 Abdominal US
 MR Cholangiography
 EUS

WHAT WE DID
 Abdominal US:
gallstones, normal gallbladder wall,
Common Bile Duct diameter 4 mm
 Repeated LFTs: unchanged

WHAT TO DO?
 Cholecystectomy + f-up
 Repeat LFTs
 MR Cholangiography
 EUS

WHAT WE DID
 EUS: 2 small Common Bile Duct Stones
3.2 mm

ERCP

A.F. 19 years old boy
 Admitted for acute cholecystitis
 LFTs: normal
Via biliare principale e vie biliari intra-epatiche non dilatate

A.F. 19 years old boy
 Admitted for acute cholecystitis
 LFTs: normal
ERCP Yes or no?

ERCP: bile duct stones, risk assssment

ERCP: bile duct stones, risk assssment
Tipo di litiasi
Tabella III N % N % N %
Litiasi della via biliare * 320 61,3 174 33,3 28 5,4
> 5 mm < 5 mm "Sludge"
Risultati a distanza della sfinterotomia endoscopica
nel trattamento della calcolosi della via biliare:
1983-1993: 522 pazienti

Bilio-pancreatic urgencies. Acute cholangitis.
It is recommended that patients not responding to initial medical treatment
(supportive care + antibiotics) undergo EARLY BILIARY DRAINAGE
Tokyo Guidelines 2012 (J Hepatobiliary Pancreat Sci)

The papilla is usually more “friendly”…

Bilio-pancreatic urgencies. Acute biliary pancreatitis.
Autopsy “… the gall-bladder contains eleven
small stones of almost uniform size and the
conformation of the common part of the biliary
and pancreatic ducts is such that any one of
these stones might block the duodenal orifice
of the two ducts…”
Eugene L Opie,
Bulletin John Hopkins
Hospital 1901

• Stones can pass spontaneously through the Oddi’s sphincter
• Stones recovered from the stool in 85-94% of patients with recent ABP
Acosta JM, NEJM 1974 – Kelly TR, Surgery 1976

ABP and ERCP … a debated history
Author Year Journal Country
Neoptolemos 1988 Lancet UK
Fan 1993 NEJM China
Folsch 1997 NEJM Germany
Nowak 1998
Endoscopy
(abstr)
Poland
Zhou 2002
J Hepatobil
Pancreat Dis Int
China
Acosta 2006 Ann Surg USA
Oria 2007 Ann Surg Argentina
Dutch
Pancreatitis
Study Group
Ongoing - The Netherlands

Pancreas 2013
8 12

Van Geenen et al, Pancreas 2013
Indicated in severe ABP with cholangitis and/or persistent cholestasis
Not indicated in mild ABP
In predicted severe ABP regardless of cholestasis ? Yes 5/8 meta-analysis
Yes 5/12 guidelines
Urgent ERCP (24-48h)

Stones extraction: technique

Stones extraction: mechanical lithotripsy

Complications: 4.5% (29/643) Trapped/Broken basket 11
Traction wire fracture 8
Broken handle 7
Perforation/duct injury 3
7 centers
retrospective

Tabella
Technique: ES + Large Balloon dilation

Technique: ES + Large Balloon dilation

Author,
Journal year
(Prospective /
Retrospective)
pts
Balloon
size
(mm)
Mean
stone
size
(mm)
Need
for
mech
Litho
(%)
Succ
clearence
(%)
AP
(%)
Bleed.
(%)
Perf.
(%)
Follow-
up
Ersoz
GIE 2003 (R)
58 10-20 17 7 100 4 8 0 ?
Heo
GIE 2007 (P)
100 12-20 16 7 97 4 0 0 ?
Maydeo
Endoscopy 2007 (P)
60 12-15 16 5 100 0 8 0 ?
Itoi
Am J Gastro 2009 (R)
53 15-20 15 5.5 100 2 0 0 ?
Draganov
J Clin Gastro 2009 (R)
44 10-15 13 4.5 95 0 0 0 ?
Kim
Surg Endosc 2011 (P)
72 12-20 > 10 8.3 97 7 0 0 ?
Youn
Dig Dis Sci 2011 (R)
101 15-20 22 6.9 100 5 2 3 ?
Procedure related mortality absent
Technique: ES + Large Balloon dilation (ESLBD)
for big bile duct stones: results

Cholangioscopy and Laser/EHL lithotripsy

Single operator “Mother baby” peroral cholangioscopy.
- Single use catheter
2007-2014
2015-
CCD (1 mm2)
“Plug and play”
 Single operator
 Disposable (video imaging sensor, illumination elements, two
irrigation channels, working channel for accessories and aspiration)
 Four way deflexion
 Useful for tissue sampling
 Digital image quality

SpyGlass DS (Digital) 2015-

Author,
Journal year
#pts Type
Succ
clearence
N°
ERCP/pt
Complications*
Arya,
Am J Gastr 2004
94 EHL 90% 1.9 18%
Piraka,
Cl Gastr Hep 2007
32 EHL 97% 1.4
10%
Jakobs,
Arq Gastro 2007
89
Laser
80% N/A 0%
Kim,
World J Gastr 2008
17
Laser
(Freddy, X-Ray control)
88% 1.7 18%
Cho,
GIE 2009
52
Laser
92% 1.4 12%
Swann,
Surg Endosc 2009
44 Laser + EHL 77% N/A 11%
Liu
Endoscopy 2011
30
Laser
90% 1.4 7%
Chen
GIE 2011
66
Laser + EHL
(SPY GLASS)
71% N/A 6%
* Mild pancreatitis, jaundice, cholangitis, haemobilia
EHL and laser lithotripsy: results

Lithostar Plus 1992-2008 LITHOSKOP 2009-

Devices: ESWL
EHL and laser lithotripsy: results

Author,
Journal / yr
# pts
Stone
diameter
Success
(%)
#
ESWL /
pts
Complications
*
Sackman
GIE 2001 313
20 mm
(8-60)
90
1.6
(1-5)
7.9%
Amplatz,
Diget Liver Dis 2007 376
21 mm
(7-80)
90
3.7
(1-12)
9.1%
Tandan
J Gastro Hepatol 2009 283
32 mm
(18-70)
84
2.8
(1-10)
15.9%
Muratori
World J Gastro 2011
214
>15
(15-50)
89
3.5
(1-14)
12.6
* Mild haemobilia, arrhythmias, mild pancreatitis, cholangitis, skin haematoma
ESWL: results

Endoscopy is
repeatable!!!
Bile duct stones
… in case of failed extraction
DRAIN the bile ducts!! (stent near the stone)

The stones of my dreams…

Benign biliary strictures: characteristics
Gallbladder Site of the stricture Stricture feature
Absent
Common bile duct /
hilum
Short
Absent
Common bile duct
(anastomosis)
Short
Present
or not
Intrapancreatic Longer

Endoscopic Therapy of Post-Operative Biliary Strictures
“Aggressive” approach
 Placement of an increasing number
of plastic stent at each stent
exchange (3 months)
 End Point: Complete morphologic
disappearance of the stricture
 Irrespective of the time of stenting
Costamagna G. GIE 2001

Post-Cholecystectomy
Benign biliary strictures amenable to “stent therapy”

Bismuth type III (after laparoscopic cholecystectomy)
4 6

Dig. End. Unit - UCSC – Rome - Italy
4
5
6
1 month later
Bismuth type II (CBD repair over T-Tube)

Drain the choleperitoneum
1 month later 3 months later

Drain the choleperitoneum
Do not mess with the bile ducts!

Dig. End. Unit - UCSC – Rome - Italy
Intra-hepatic leak following cholecystectomy
2 months later

Long-term results of endoscopic treatment
with multiple plastic stents
160/180 (88.8%) patients: 7 years mean follow-up
 86.3% (n 138) asymptomatic
 13.7% (n 22) symptomatic recurrences (cholangitis)
 8.7% (n 14) Stricture recurrence
 5% (n 8) Stones
Endoscopic Therapy of Post-Cholecystectomy Biliary Strictures
“Aggressive” approach
Digestive Endoscopy Unit, UCSC, Rome
UEGW 2012
Time to recurrence: 2.5 y (0.2-12)
Success of endoscopic retreatment: 100%
Mean follow-up after retreatment: 4.8 y

Post-Liver Tx anastomotic stictures

2 5 74 6
Endoscopic Therapy of Post-Liver Tx anastomotic strictures
Multiple plastic stents

Endoscopy 2016
1
3
7
51 patients
50/51 (98%) technical success
3/50 (6%) stricture recurrence
(median F-up 5.8 years, range 0.8 – 18.6 y)

Pro
• Effective and satisfactory results
• Few major complications
• Related mortality absent
• Low stricture recurrence rate
• Endoscopic re-treatment feasible
and successful
Cons
• Need for several ERCPs (2-7)
• Usually 1 year treatment
• Patient compliance
• Risk of cholangitis (stent
displacement / occlusion)
Endoscopic Therapy of Benign Biliary Strictures
Multiple plastic stents

Fully Covered Removable Metal Stents

Author, year Etiology Pts
Patients with
post-operative stricture
(excluding OLT)
Kahaleh,
GIE 2008
CP, stones, OLT, PO, AI, 65 3
Mahajan,
GIE 2009
CP, stones, OLT, AI, PSC 41 0
Moon,
GIE 2012
CP, stones, OLT, PO, PSC,
post traumatic, vascular,
pancreatic cystic neoplasm
21 4
Tarantino,
Endoscopy 2012
CP, stones, OLT, PO, PSC 62 9
Poley,
GIE 2012
CP, Cholecystectomy,
papillary stenosis
23 9
Devière,
Gastroenterology 2014
CP, Cholecystectomy, OLT 187 18
Fully Covered Removable Metal Stents: RESULTS
?
CP, chronic pancreatitis OLT, orthotopic liver transplantation;
PO, post-operative AI, autoimmune pancreatitis
PSC, primary sclerosing cholangitis

Author, year Pts
Median
stenting
duration
(months)
SEMS
migration
(%)
Success
in SEMS
removal
(%)
Stricture
resolution
(%)
Mean
follow-up
after SEMS
removal
(months)
Stricture
recurrence
(%)
Chaput,
GIE 2010
22 2 27 100 86 12 47
Tarantino,
Endoscopy 2012
54 2 37 100 67 18 16
Hu,
J Hepatobil
Pancreat Sci 2011
12 5 0 100 92 13 9
Devière et al,
Gastronterology
2014
42 4-6 74 100 68 20 27
Endoscopic Therapy of Post-Liver Tx anastomotic strictures

Possible advantages
• Potentially 2 ERCPs
• SEMS larger diameter than plastic
Disadvantages
• Stricture < 2 cm from the main
hepatic confluence excluded
• Removability not always “easy”
10 french
10 mm
1 2
76
5 4
3

1 2
ERCPs
6
months
later

After
10 months
12 mm
Difficult SEMS Removal
2 months
later SEMS in SEMS
1 month
later

Bile duct strictures in chronic pancreatitis

Study N°
Stent
design
Median
time to
SEMS
removal
(months)
Stricture
resolution
rate at SEMS
removal, %
Migration
rate %
Complications
%
Median
f-up after
stent
removal,
(months)
Cahen et al
Eur J Gastro
Hepatol 2005
6 FC-SEMS 5.5 67 33 67 20.5
Behm et al
Endoscopy
2009
20 PC-SEMS 5 80 5 4 22
Mahajan et al
GIE 2009
19 FC-SEMS NA 58 5 16 NA
Perri et al
GIE 2012
7
10
UE-SEMS
FE-SEMS
6
43
90
100
40
57
10
24
Devière et al
Gastronterology
2014
127 FC-SEMS 11.3 79 NA NA 20.3
FC-SEMS= fully covered SEMS UE-SEMS= unflared ends SEMS
PC-SEMS= partially covered SEMS FE-SEMS= Flared ends SEMS
NA= Not applicable

Rome,Brussels, Hyderabad, Vienna, Lyon, Rotterdam, Sydney,
Dusseldorf, Montréal(2), Girona, Toronto, Santiago del Cile
187 patients enrolled
127 CP
42 OLT
18 Post-cholecystectomy
Prospective multicenter trial (13 centers – 11 countries)

Devière et al, Gastroenterology 2014
Prospective multicenter trial (13 centers – 11 countries)

Devière et al, Gastroenterology 2014

Stent in Benign biliary strictures.
Conclusions
Results
Long-term f-up
Hilar strictures
Endoscopic
re-treatment
Removability
Better
Post-cholecystectomy and OLT
Slightly better
CP related biliary stricture
Yes No
Applicable Not applicable
Usually “easy” Could be a challenge
Always feasible Always feasible

Chronic calcifying pancreatitis: stones and strictures

CP related pancreatic duct strictures. Single stent results.
Placement of a single pancreatic plastic stent achieves
MPD stricture resolution in nearly 60% of cases
(Evidence level 2+)
Endoscopy 2012

CP related pancreatic duct strictures. “Multistenting”.
6 months later
Clogged
stent removal
6-10 mm
balloon dilation
Insertion of the maximum
number of stents
Stent removal
after 6 months

Dilation of MPD strictures by multiple stents:
Overall Success
89.5% (43/48)
5 (10.5%) failures: patients chose to continue with
annual single plastic stent exchange (ESGE GL 2012)
Dig End Unit UCSC – UEGW 2016
Pancreatic stenting in chronic pancreatitis.
“Multistenting” long-term results (48 pts).

Mean follow−up: 9.5 years (range 0.3-15.5)
75% (32/43) asymptomatic (no pain, normal amylase and lipase)
25% (11/43) pain and stricture recurrence after a mean time of
2.2 years from multiple plastic stents removal
(3 re-stenting, 8 duct clearance)
Dig End Unit UCSC – UEGW 2016
Pancreatic stenting in chronic pancreatitis.
“Multistenting” long-term results (43 pts).

Pancreatic duct disruption.
Post traumatic Post acute pancreatitis
Post surgical
Fall
from horse
7 years old
Fall
from bicicle

Pancreatic duct rupture+fistula. Post traumatic.
7 French, 9 cm
After 2 months
LM, 23 years old,
car accident.

8.5 French
After 10 French stent
Pancreatic duct disruption. Post surgical.

ERCP: bile ducts stenting
10 french
30 french

before 1980
Surgical bypass
Percutaneous –
Endoscopic plastic stenting
in 90’s
Self Expandable Metal Stents
Biliary drainage …. The history

Biliary stents for malignant common bile duct strictures
Palliation: role of SEMS
SEMS better than plastic?
Covered or Uncovered?
Cost-effective?
Role in chemotherapy?

Cost-effective?
10 french30 french

Moss AC et al, Eur J Gastroenterol Hepatol 2007
Plastic vs Metal stents for malignant common bile duct obstruction
Meta-analysis of 7 RCT
Metal stents:
• Less RR of stent occlusion at 4 months (p<0.01)
• Lower risk of recurrent biliary obstruction (p<0.01)
• Median patency 111-273 days (62-165 for plastic)

Cost-effective?

Problems with Uncovered SEMS: Ingrowth

Partially Covered Wallstent
Old type (1991)
After 3 months
Polyurethane covering:
dissolves in bile
Present type removed
after 2 years!!
Covered with
Permalume

Amongst SEMS models measuring 10 mm
in diameter, no difference has been clearly
demonstrated, including between covered
and uncovered models.
(Evidence level 1+)
Endoscopy 2012

Increased risk of cholecystitis with Covered SEMS?

Suk KT, Isayama H,
GIE 2006 Eur J Gastr Hepatol 2006
(155 pts) (246 pts)
Incidence of cholecystitis 9.7% 5.3%
Covered 10% 6%
n.s.
Uncovered 11% 4%
Risk factors for cholecystitis (multivariate analysis):
• Obstruction of the cystic duct orifice by the tumor
• Presence of gallbladder stones Suk KT et al, GIE 2006
Retrospective studies
Risk factors for cholecystitis after metal stenting
for malignant biliary obstruction

€
Cost-effective?

Metal Biliary Stents: EXPENSIVE
10-15 times more than plastic

Moss AC et al, Eur J Gastroenterol Hepatol 2007
Plastic vs Metal stents for malignant common bile duct obstruction
Meta-analysis of 7 RCT
Metal stents:
• Cost-effective in patients surviving > 6 months
Initial higher cost of SEMS is balanced by a decreased
need for reintervention if survival > 4 months
(no distant metastases)
Soderlund and Linder, GIE 2006

SEMS present a lower risk of recurring biliary obstruction than plastic
(Evidence level 1+).
Plastic stent cost-effective if life expectancy < 4 months;
SEMS cost-effective if life expectancy ≥ 4 months;
(Evidence level 2+).
Initial insertion of a 10-Fr plastic stent is recommended if the diagnosis of
malignancy is not established (Recommendation grade C).
Endoscopy 2012

Cost-effective?

World J Gastroenterol 2006
Plastic
(Double
Layer)
Metal
Covered
p
Median survival
time (months) 10.1 9.8 n.s
Stent occlusion
(%) 60 7 0.0002
Median stent
patency
(months)
5 7.5 0.03
• Metal stents reduce the risk of chemotherapy
postponement due to stent occlusion (more frequent
with plastic stents)
• Chemotherapy (Gemcitabine) does not prolong stent
patency (plastic or metal)

Endoscopy 2012
Prefer SEMS in patients who are candidates
for neoadjuvant therapies
(Recommendation grade C).

Is necessary?
Can SEMS impair surgery?
Covered or uncovered SEMS?

In patients with a resectable malignant CBD stricture,
insertion of a plastic biliary stent followed by delayed surgery
is associated with a higher morbidity compared to surgery
at one week (Evidence level 1++).
Lai EC et al. Br J Surg 1994
van der Gaag NA et al. N Engl J Med 2010
Wang Q et al. Cochrane database of systematic reviews (Online) 2008
Pre-operative drainage: not routinely necessary

Pre-operative drainage: not routinely necessary
Efficacy of preoperative biliary drainage in
malignant obstructive jaundice:
a meta-analysis and systematic review
26 studies (1981-2011) (8 RCTs)
3532 patients (endoscopic and percutaneous drainage)
Less adverse events without pre-operative drainage
Moole H et al, WJ Surgical Oncology 2016

Pre-operative drainage: when?
Preoperative drainage of potentially resectable malignant
CBD obstruction only in:
• delayed surgery
• candidates for neoadjuvant therapies
• intense pruritus
• acute cholangitis
(Recommendation grade A)

Pre-operative endoscopy: common bile duct malignant stricture
107
• Bilirubin too high????? a definition
van der Gaag,
2010
RCT Excluded if Bilirubin ≥ 14.6 mg/dl
Haapamäki,
2014
Retrospective Mean bilirubin 10 mg/dl ± 3.5
Tol, 2015 Prospective Mean bilirubin 12 mg/dl (range 1-39)
Song, 2016 RCT Included if bilirubin ≥ 5 mg/dl
(enrolled with a mean bilirubin of 9 ± 5.5)
≥ 15 mg/dl

Is necessary?

Pre-operative drainage: common bile duct malignant stricture
109
Pre-operative endoscopy: when, why and how? | Guido Costamagna
Covered SEMS can be removed intraoperatively
and uncovered “en-bloc” with the surgical
specimem
Mullen JT, J Gastrointest Surg 2005
Kahaleh M, Endoscopy 2007
Briggs CD, Surg Endosc 2010
Siddiqui AA et al, J Clin Gastro 2011
Cavell LK et al, Am J Gastroenterol 2013
4-6 cm uncovered

110
Crippa S et al, Eur J Surg Oncol 2016
5 studies included (1 RCT, 4 retrospective monocentric)
Plastic SEMS p
N 502 202
Need for re-intervention (%) 14.8 3.4 0.001
Post-operative pancreatic fistula (%) 11.8 5.1 0.04
Post-operative complications (%) 47 39 ns
Post-operative mortality (%) 15 6 ns
Systematic review and meta-analysis of metal versus
plastic stents for preoperative biliary drainage in
resectable periampullary or pancreatic head tumors

111
Tol JA et al, Gut 2015
Metal or plastic stents for preoperative biliary drainage in
resectable pancreatic cancer (prospective multicenter study)
Plastic FC-SEMS p
N 102 53
Pre-operative complications (%) 46 24 0.01
Surgical complications (%) 47 40 ns
Overall complications (%) 74 51 0.01
FCSEMS should be preferred over plastic stents
whenever pre-operative drainage is indicated.

112
ESGE recommends the insertion of a 10 mm diameter
fully covered SEMS which provides better jaundice
resolution and a reduced risk of preoperative
cholangitis compared to plastic stents.
Short, intrapancreatic, biliary SEMS, not bridging the
main hepatic confluence do not impede pancreatic
resection.
ESGE Guidelines on biliary stents, 2017 update (under review)

Is necessary?
Covered preferred
but consider presence of the gallbladder

114
 Metal stents or direct surgery? Work in progress!
RCT (10 centers)
No pre-op drainage
Vs
Drainage with SEMS
Enrollment aim 294 pts
Enrolled if
Bilirubin ≥ 5 mg/dl

… an ideal world
115
• 8.00 am – ER admission for jaundice – no pain: bilirubin 5 mg/dl
• 8.30 am – Transabdominal US: CBD dilation; no stones
• 9.30 am – CT Scan: 1.5 cm pancreatic mass, M0, no vascular invasion
• 11.00 am – EUS+FNA…
… 3.00 pm results from the Pathology Department
• 4.00 pm – Meeting with surgeons, anaesthesiologists, oncologists
 … the day after
• 8:00 - Pancreaticoduodenectomy

… the real world
116
Delayed diagnosis
• General practitioner
• Community hospital
Difficult staging
• Old CT-scan
• No access to EUS facilities
Delayed therapies
• Pancreatic surgery only in referral centres
• Busy operating rooms
Worsening
cholestasis & jaundice

Cost-effective?
Yes
Yes, if expected survival
> 4 months (no metastases)
Presence of the gallbladder can
also drive the choice
Longer stent patency,
less therapy interruption
Biliary stents for malignant common bile duct strictures.
Conclusions

Is necessary?
Can SEMS impair surgery
Not routinely
No, if short and
covered
Biliary stents for malignant common bile duct strictures.
Conclusions

119

Tringali A. La CPRE. ASMaD 2016

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