Early ERCP and biliary sphincterotomy with or without small caliber pancreatic stent in patients with gallstone pancreatitis(nonrandomized, prospective, dual center trial)

Z.Dubravcsik1, A.Szepes1, R.Fejes2, G.Balogh2, Z.Virányi1, P.Hausinger1, A.Székely2, L.Madácsy2

1Gastroenterology and Endoscopy, Bács-Kiskun Megyei Önkormányzat Hospital, Kecskemét,

2First Department of Internal Medicine and Gastroenterology, Fejér Megyei Szent György Hospital, Székesfehérvár,

HUNGARY

Introduction – acute pancreatitis Incidence: 5-73 /100,000 Mortality: 5-15 % Severe (SAP): 20 % Biliary origin: 38 % ERCP, EST within 72 hours (SABP)

Yamada (ed): Textbook of Gastroenterology, 5th ed., Blackwell Publisging, 2009.

McDonald, Burroughs, Feagan (ed): Evidence Based Gastroenterology and Hepatology, 2nd ed., Blackwell Publishing,2004.

Tonsi et al: Acute pancreatitis at the beginning of the 21th century, World J Gastroenterol, 2009; 15(24):2945-59.

Recent Meta-Analysis of Early ES in Acute Biliary Pancreatitis

Year Author No of RCTs (patients)

Outcomes

2006 Heinrich 3 (455) Reduction of overall complications and mortality

2008 Moretti 5 (702) Reduction of pancreatitis-related complications

2008 Petrov 3 (450) Overall complications and mortality not affected in the absence of cholangitis

2009 Manley 2 (340) Non-significant trend of increased mortality in early ERCP groupCLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2009;7:S3–

S9

Pathophysiology –acute biliary pancreatitis

Duct obstruction

Acinar cell injury

Defective intracellular

transport

Trypsinogen

Trypsin

Kumar, Abbas, Fausto (eds): Robbins and Cotran Pathologic Basis of Disease, 7th ed., Elsevier Saunder, 2005.

Hypothesis – Why early ERCP and EST is ineffective in recent RCT with ABP patients without cholangitis?

In certain subgroups of patients ERCP and repeated PD cannulation with contrast filling may cause further pancreatic injury (similarly to patients with post-ERCP pancreatitis)

EST and gallstone extraction from the CBD itself does not completely relieve the pancreatic duct obstruction, which may be due to:

- Papillary edema and inflammation caused by spontaneous gallstone migration or EST itself

- Prolonged spasm of the pancreatic sphincter due to paradoxical response of the SO evoked by high plasma levels of CCK

Introduction – Feasibility trial of PD stent application in ABP Post-ERCP pancreatitis

Acute biliary pancreatitisGodi et al: Emergency pancreatic drainage with postponed biliary

sphincterotomy in patients with acute biliary pancreatitis: sparing little time may save a lot, Endoscopy 2008; 40 (Suppl 1): A 412.

Fejes at al: Feasibility and safety of emergency ERCP and small-caliber pancreatic stenting as a bridging procedure in patients with acute biliary pancreatitis but difficult sphincterotomy, Surg Endosc, 2010; 24:1878-1885.

Freeman et al: Pancreatic stents for prevention of post-ERCP pancreatitis, Clin Gastroenterol Hepatol 2007; 5: 1354-65.

Madácsy et al: Prophylactic pancreas stenting followed by needle-knife fistulotomy in patients with SOD and difficult cannulation: new method to prevent post-ERCP pancreatitis, Dig Endosc, 2009; 21: 8-13.

Madácsy et al: Rescue ERCP and insertion of a small-caliber pancreatic stent to prevent the evolution of severe post-ERCP pancreatitis: a case-controlled series, Surg Endosc, 2009; 23 (8):1887-93.

Methods – prospective nonrandomized study

Dual large volume endoscopic center (Kecskemét + Székesfehérvár County Hospital, >800 ERCP/year)

Non-alcoholic pts (n=116) Biliary pancreatitis with cholangitis

Gallbladder stones ± dilated CBD Elevated obstructive LFTs and WBC

(>1.5N) EST (n=59) vs. EST+PD stent (n=57) Hospitalization, treatment (medical

therapy, jejunal feeding), follow up (CT)

Hospitalization Admission

History, physical examination Blood tests, abdominal USS

ERCP (<72 hours from onset of pain) Contrast enhanced CT scan

On day 3-5 Follow up (at emission or day 10)

Blood tests, USS

Indications for small caliber PD stent implantation

Severe papillary edema due to impacted gallstone

Repeated PD contrast filling (>5x) Repeated PD cannulation (>5x) Difficult biliary cannulation (>5x

unsuccessful cannulation attempts during > 10 min)

Use of needle knife precut papillotomy

Small caliber PD stents used

Geenen® stent (5 Fr) Inner and duodenal flaps

and sideholes Length: 3-5 cm 0,025 F hydrophilic

guidewire (until the border of pancreas head and body)

Minimizing further PD contrast filling

Stent extraction after 10 days with gastroscope

5 F, 3-5 cm

www.cookmedical.com

ABP, impacted gallstone:urgent ERCP, EST, PD stenting

Results – demographyPD stent(n = 57)

Control(n = 59) p

Age (years) 59.4 63.3 0.18

Pain-ERCP time (h) 36.3 42.1 0.37

Hospitalization (days) 11.58 12.5 0.58

Ranson (initial) 2.23 2.1 0.57

Results - gender

17 18

40 41

0%10%20%30%40%50%60%70%80%90%

100%

PD stent Control

FemaleMale

Results - LFTsPD stent(n=57)

Control(n=59) p

bilirubin 53.17 65.2 0.37

GOT/ASAT 335.4 273.8 0.2

GPT/ALAT 364.2 312.1 0.29

GGT 572.3 568.1 0.97

ALP 520.5 579.2 0.32

Results - FBC, amylase, CRP

PD stent(n=57)

Control(n=59) p

WBC 13.4 12.9 0.53

Hgb 142.3 136.8 0.1

Blood glucose 8.1 8.9 0.16

Amylase 2224.8 1878.6 0.313

Max. CRP 141.4 126.3 0.65

Outcome

12

3

12

4

9

1

0123456789

10

ICU Sepsis Pseudocyst Opus

PD stent (n=57)Control (n=59)

2x

2x

3x

3.3%1.7%

6.7%

3.5%5.3%

15.2%

1.7% 1.7%

Outcome

0

7

2

18

0

24

6

810

12

14

1618

20

Mortality Overall complications

PD stent (n=57)Control (n=59)

NS

p <0.02X2=5.69

7

3.3%

12.2%

30.5%

Conclusion Early ERCP and EST with small caliber PD

stenting is better to conventional EST alone: May offer sufficient drainage to reverse the

process of ABP Results significantly less complications Results better outcome It could be a new endoscopic therapeutic

strategy, but randomized controlled trials are necessitated to support this innovative approach