Prospective, randomized, controlled trial of prophylactic pancreatic stent placement for endoscopic snare excision of the duodenal ampulla

Gastrointest Endosc. 2005 Sep;62(3):367-70. doi: 10.1016/j.gie.2005.04.020.


Background: Tumors that arise in the region of the major duodenal papilla account for 5% of GI neoplasms and 36% of resectable pancreaticoduodenal tumors. There is limited published literature that addresses the safety of endoscopic excision of the papilla. Although there is consensus about prophylactic pancreatic-duct stent placement, there is little supporting prospective data. The aim of this randomized, controlled trial was to compare the rates of postsnare ampullectomy pancreatitis in patients who did/did not receive prophylactic pancreatic-duct stent placement.

Methods: Consecutive patients who were to undergo en bloc snare ampullectomy were randomized to placement of pancreatic-duct stent after ampullectomy or to no stent placement.

Results: In total, 19 patients were enrolled, and 10 received pancreatic stents. Postprocedure pancreatitis occurred in 3 patients in the 24 hours after endoscopy, all cases occurred in the unstented group, 33% vs. 0% (stented group), p = 0.02. Median peak amylase level was 3692 U/L (range 1819-4700 U/L) and median peak lipase level was 11450 U/L (range 5900-17,000 U/L). All 3 patients were hospitalized for a median of 2 days (range 1-6), and all made a complete recovery.

Conclusions: Our findings suggest that a protective effect is conferred by pancreatic stent placement in reducing postampullectomy pancreatitis. Future large-scale studies are required to confirm this benefit.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Ampulla of Vater / pathology
  • Ampulla of Vater / surgery*
  • Cholangiopancreatography, Endoscopic Retrograde / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Minimally Invasive Surgical Procedures / methods
  • Neoplasm Staging
  • Pancreatic Ducts / pathology
  • Pancreatic Ducts / surgery*
  • Pancreatic Neoplasms / mortality
  • Pancreatic Neoplasms / pathology
  • Pancreatic Neoplasms / surgery*
  • Pancreatitis / prevention & control*
  • Postoperative Complications / prevention & control
  • Probability
  • Prognosis
  • Prospective Studies
  • Risk Assessment
  • Sphincterotomy, Endoscopic / methods*
  • Stents*
  • Survival Rate
  • Treatment Outcome