Prophylactic Pancreatic Duct Stent Placement After Endoscopic Snare Papillectomy of Duodenal Major Papillary Tumors; Prospective, Randomized, Controlled Study
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 oriļ¬ce. 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 stent placement, a plain abdominal radiograph was obtained to determine its position.
If it had not passed spontaneously, it was removed endoscopically from those patients with
no evidence of pancreatitis.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study
The incidence of post-ESP pancreatitis and hyperamylasemia
after October 1, 2012 (up to 2 years)
Yes
Sang-Woo Cha, PhD
Study Chair
Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
Korea: Institutional Review Board
MD-2012-04
NCT01737463
March 2010
October 2014
Name | Location |
---|