Clinical trial NCT01737463: Prophylactic Pancreatic Duct Stent Placement After ESP of Major Papillary Tumors; Prospective, Randomized Study
Official title: Prophylactic Pancreatic Duct Stent Placement After Endoscopic Snare Papillectomy of Duodenal Major Papillary Tumors; Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ampulla of Vater Adenoma
Keywords: Ampulla of Vater adenoma
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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 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.

Eligibility criteria: Inclusion Criteria:

* Age: 20 to 80 years, Histopathologically proven ampullary adenoma

Exclusion Criteria:

* Lesions with irregular margin, ulceration and spontaneous or easy to bleeding which presenting malignancy.
* Extensive lesion into PD or BD on ERCP, EUS or IDUS.
* Tumor size \> 4cm
* Bleeding tendency

Primary outcomes:
measure: Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study
timeFrame: after October 1, 2012 (up to 2 years)
Secondary outcomes:
measure: Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study
timeFrame: after October 1, 2012 (up to 2 years)
Other outcomes:
Locations:
city: Yongsan-gu
country: Korea, Republic of
facility: Institute for Digestive Research, Digestive Disease center, Department of Internal Medicine, Soonchunhyang University College of Medicine
state: Seoul
Study officials:
affiliation: Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
name: Sang-Woo Cha, PhD
role: STUDY_CHAIR
References: