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

Ampulla of Vater Adenoma Clinical Trial

— PDS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01737463
• Other study ID #: MD-2012-04
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: November 16, 2012
• Last updated: December 1, 2012
• Start date: March 2010
• Est. completion date: October 2014

Study information

• Verified date: December 2012
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ampulla of Vater Adenoma

Intervention

Procedure:
• Endoscopic snare papillectomy
Endoscopic snare papillectomy (ESP) was performed by using diagnostic or therapeutic duodenoscope. A pancreatic duct stent was or was not inserted immediately after the excision.

Locations

Country	Name	City	State
Korea, Republic of	Institute for Digestive Research, Digestive Disease center, Department of Internal Medicine, Soonchunhyang University College of Medicine	Yongsan-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study	The incidence of post-ESP pancreatitis, hyperamylasemia and post-ESP pancreatitis risk factors was compared between the groups.	after October 1, 2012 (up to 2 years)	Yes