PREPAST

Twenty per cent of acute biliary pancreatitis (ABP) is severe, carrying a risk for severe, even potentially lethal complications. Its therapy includes early endoscopic retrograde cholangiography (ERCP), endoscopic sphincterotomy (EST) and stone extraction from the common bile duct within a specific timeframe (eg. therapeutic window).Endoscopic therapy has been debated since the first metaanalysis in 2008 and this debate is still ongoing even after the new guidelines. The contradictory results could be caused by a few facts: firstly that ERCP can cause further pancreatic damage similarly to post-ERCP pancreatitis and secondly that early endoscopic intervention does not always relieve the pancreatic duct obstruction.

We demonstrated in our previous study that using small calibre (ie. preventive) pancreatic stents (PPS) at the early course of ABP significantly improves the outcome.

Based on these data we hypothesize that PPS insertion not just prevents the injury caused by ERCP but may be beneficial for every ABP patient by maintaining the outflow of pancreatic juices. Our aim is to investigate this therapy in a multicentre randomized clinical trial.

The main question of this trial is whether using PPS at the early course of ABP can cause significantly fewer complications and therefore better overall outcome compared to the standard ERCP techniques irrespective of the degree of cannulation difficulty, co-existing acute cholangitis and the proposed severity of ABP at admission. Furthermore, we would like to investigate the success rate of PPS insertion and its technical details (eg. influence of endoscopist’ experience on final outcome) and the consequences of attempted but failed PPS insertion.

Please NOTE that our RCT has (i) been discussed and (ii) accepted in a distinguished international scientific meeting. (iii) Many international centres have been joined. The RCT has the (v) relevant ethical approval, (vi) been registered at the ISRCTN registry which is a primary clinical trial registry recognised by WHO and the trial article has been submitted for publication (Pancreatology, 30.12.2014).

If you plan to join the trial, please contact Dr. Zsolt Dubravcsik or Dr. Peter Hegyi.

Dr. Dubravcsik Zsolt

Tel: +36 30 959 9257

dubravcsikzs@gmail.com

Ethical approval number: 034 5 24/2014/OTIG

Trial registration number: ISRCTN13517695