Clinical Trial: Prophylactic Pancreatic Duct Stent Placement After ESP of Major Papillary Tumors; Prospective, Randomized Study

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prophylactic Pancreatic Duct Stent Placement After Endoscopic Snare Papillectomy of Duodenal Major Papillary Tumors; Prospective, Randomized, Controlled Study

Brief Summary:

Endoscopic snare papillectomy (ESP) is an efficient treatment for benign tumors of the duodenal major papilla. But post-ESP pancreatitis is the most common and serious complication. Since one prospective randomized controlled trial showed that pancreatic duct stent placement reduced post-ESP pancreatitis, almost physicians have tried to place the pancreatic duct stent after EPS.

The aim of this prospective, randomized, multicenter trial is to compare the rates of post-ESP pancreatitis in patients who did or did not prophylactic pancreatic duct stent placement. Consecutive patients who were to undergo ESP were to randomized to pancreatic duct stent placement group (stent group) after endoscopic snare papillectomy or to no pancreatic duct stent placement group (no stent group).

Detailed Summary: The patient was adequately sedated by intravenous administration of midazolam with or without meperidine. ESP and pancreatic duct stent insertion were undertaken using two methods: conventional and wire-guieded ESP. The conventional ESP method was performed as in the follows. After placing the tip of the duodenoscope on the tumor, the snare was deployed so that it grasped the base of the tumor. Constant tension was applied to the snare loop during excision until the lesion was transected. Excision was performed with a small sized electrosurgical snare. A pancreatic duct stent was or was not inserted immediately after the excision. The wire-guided ESP method was performed as follows. An ERCP catheter was inserted into the pancreatic duct. Then, a 0.035-inch guidewire was inserted through the catheter and deep into the main pancreatic duct. After the ERCP catheter was removed, the loop of an electrosurgical snare with a maximum sheath diameter of 1.8 mm was passed over the guidewire, in monorail fashion, and the snare was closed lightly. The snare was introduced next to the guidewire into the accessory channel of the duodenoscope. After the tip of the duodenoscope was placed on the tumor, the snare was deployed so that it grasped the base of the tumor. Constant tension was applied to the snare loop during excision until the lesion was transected. After the excision was completed, a pancreatic duct stent was immediately passed over the guidewire previously placed in the pancreatic duct and was positioned across the pancreatic-duct orifice. ESP was performed by using the blend mode or endocut mode setting on the electrosurgical generator. A straight or single pigtail type, 3- to 9-cm, 3 to 7F polyethylene pancreatic duct stent was used. Post-papillectomy bleeding was treated with argon plasma coagulation (APC) and/or endoscopic clipping or epinephrine injection. APC was carried out with a power setting of 60 W and a gas flow of 2 L/min. One to seven days after ste
Sponsor: Soonchunhyang University Hospital

Current Primary Outcome: Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study [ Time Frame: after October 1, 2012 (up to 2 years) ]

Original Primary Outcome: Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study [ Time Frame: after October 1, 2012 ]

Current Secondary Outcome: Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study [ Time Frame: after October 1, 2012 (up to 2 years) ]

Original Secondary Outcome: Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study [ Time Frame: after October 1, 2012 ]

Information By: Soonchunhyang University Hospital

Dates:
Date Received: November 16, 2012
Date Started: March 2010
Date Completion: October 2014
Last Updated: December 1, 2012
Last Verified: December 2012