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

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

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).

Study Overview

• Status: Unknown
• Conditions: Ampulla of Vater Adenoma
• Intervention / Treatment: Procedure: Endoscopic snare papillectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Yongsan-gu, Seoul, Korea, Republic of, 140-743
      • Institute for Digestive Research, Digestive Disease center, Department of Internal Medicine, Soonchunhyang University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Endoscopic snare papillectomy (ESP) was performed by using diagnostic or therapeutic duodenoscope (JF-240, TJF-240, JF-260, TJF-260; Olympus Optical Co, Ltd, Tokyo, Japan). A pancreatic duct stent was inserted immediately after the excision.	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.
Active Comparator: Group B; Endoscopic snare papillectomy (ESP) was performed by using diagnostic or therapeutic duodenoscope (JF-240, TJF-240, JF-260, TJF-260; Olympus Optical Co, Ltd, Tokyo, Japan). A pancreatic duct stent was not inserted immediately after the excision.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Study Chair: Sang-Woo Cha, PhD, Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 1, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Ampulla of Vater adenoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: MD-2012-04