Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: A Prospective, Randomized Trial.
OBJECTIVE
Prophylactic pancreatic stent placement is effective for preventing postendoscopic retrograde cholangiopancreatography pancreatitis (PEP). The most effective type of stent, however, remains unclear. Therefore, we prospectively compared the prophylactic efficacy for PEP prevention between short (3 cm) and long (5 cm) pancreatic stent.


METHODS
Between July 2012 and June 2014, 240 consecutive patients requiring therapeutic endoscopic retrograde cholangiopancreatography to remove a choledocholith or for bile drainage for obstructive jaundice were prospectively enrolled and randomized to undergo prophylactic insertion with unflanged, 5 Fr, 3 or 5-cm pancreatic stent. An efficacy of each stent for preventing PEP was evaluated as a primary endpoint. The period until stent dislodgement and the total adverse event rate were also evaluated as a secondary endpoint.


RESULTS
Per-protocol analysis revealed that the PEP rate was significantly lower with the short stent than with the long stent (2.0% vs. 8.8%, P=0.035), although they were not significantly different in intention-to-treat analysis. The adverse event rate excluding PEP did not differ significantly between groups (3.0% vs. 0.9%, P=0.293). The median period until dislodgement of the short stent was significantly shorter than that of the long stent (2 vs. 4 d, P<0.001).


CONCLUSIONS
The present study revealed a superiority of 3-cm stents compared with 5-cm stents for prophylactic pancreatic stent. On the basis of the past reports and the result of the present study, we recommend using a 5 Fr, 3-cm unflanged stent.This study was registered on the UMIN Clinical Trial Registry (UMIN000008290).
*Department of Gastroenterology, NTT Medical Centre Tokyo, Tokyo †Gastroenterology Division, Yokohama City University School of Medicine, Yokohama ‡Department of Health Policy and Technology Assessment, National Institute of Public Health, Saitama, Japan.
Toshio
T
Fujisawa
Koichi
K
Kagawa
Kazushige
K
Ochiai
Kantaro
K
Hisatomi
Kensuke
K
Kubota
Hajime
H
Sato
Atsushi
A
Nakajima
Nobuyuki
N
Matsuhashi
D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D042883:Choledocholithiasis / Q000628:therapy; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D041781:Jaundice, Obstructive / Q000628:therapy; D008297:Male; D010183:Pancreatic Ducts; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D015607:Stents / Q000009:adverse effects; D013997:Time Factors