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Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: A Prospective, Randomized Trial.
J Clin Gastroenterol 2016; 50(3):e30-4JC

Abstract

BACKGROUND AND STUDY AIMS

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.

PATIENTS AND 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).

Authors+Show Affiliations

*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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26280707

Citation

Fujisawa, Toshio, et al. "Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: a Prospective, Randomized Trial." Journal of Clinical Gastroenterology, vol. 50, no. 3, 2016, pp. e30-4.
Fujisawa T, Kagawa K, Ochiai K, et al. Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: A Prospective, Randomized Trial. J Clin Gastroenterol. 2016;50(3):e30-4.
Fujisawa, T., Kagawa, K., Ochiai, K., Hisatomi, K., Kubota, K., Sato, H., ... Matsuhashi, N. (2016). Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: A Prospective, Randomized Trial. Journal of Clinical Gastroenterology, 50(3), pp. e30-4. doi:10.1097/MCG.0000000000000397.
Fujisawa T, et al. Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: a Prospective, Randomized Trial. J Clin Gastroenterol. 2016;50(3):e30-4. PubMed PMID: 26280707.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: A Prospective, Randomized Trial. AU - Fujisawa,Toshio, AU - Kagawa,Koichi, AU - Ochiai,Kazushige, AU - Hisatomi,Kantaro, AU - Kubota,Kensuke, AU - Sato,Hajime, AU - Nakajima,Atsushi, AU - Matsuhashi,Nobuyuki, PY - 2015/8/18/entrez PY - 2015/8/19/pubmed PY - 2016/11/8/medline SP - e30 EP - 4 JF - Journal of clinical gastroenterology JO - J. Clin. Gastroenterol. VL - 50 IS - 3 N2 - BACKGROUND AND STUDY AIMS: 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. PATIENTS AND 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). SN - 1539-2031 UR - https://www.unboundmedicine.com/medline/citation/26280707/Prophylactic_Efficacy_of_3__or_5_cm_Pancreatic_Stents_for_Preventing_Post_ERCP_Pancreatitis:_A_Prospective_Randomized_Trial_ L2 - http://Insights.ovid.com/pubmed?pmid=26280707 DB - PRIME DP - Unbound Medicine ER -