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

NCT01737463 | Unknown Phase 4

• 1 other identifier: MD-2012-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Ampulla of Vater Adenoma

Keywords

Ampulla of Vater adenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study

  after October 1, 2012 (up to 2 years)

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Interventions

Endoscopic snare papillectomy PROCEDURE

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.

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Institute for Digestive Research, Digestive Disease center, Department of Internal Medicine, Soonchunhyang University College of Medicine

Yongsan-gu, Seoul, 140-743, South Korea

Location

Study Officials

• Sang-Woo Cha, PhD

  Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SoonchunhyangUH

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 29, 2012
• Study Start: March 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

KR (1)