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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Byung Hoo Lee, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01737463
First received: November 16, 2012
Last updated: December 1, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Ampulla of Vater Adenoma
Procedure: Endoscopic snare papillectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prophylactic Pancreatic Duct Stent Placement After Endoscopic Snare Papillectomy of Duodenal Major Papillary Tumors; Prospective, Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study [ Time Frame: after October 1, 2012 (up to 2 years) ] [ Designated as safety issue: Yes ]
    The incidence of post-ESP pancreatitis and hyperamylasemia


Secondary Outcome Measures:
  • Prophylactic pancreatic duct stent placement after endoscopic snare papillectomy of duodenal major papillary tumors; prospective, randomized, controlled study [ Time Frame: after October 1, 2012 (up to 2 years) ] [ Designated as safety issue: Yes ]
    The incidence of post-ESP pancreatitis, hyperamylasemia and post-ESP pancreatitis risk factors was compared between the groups.


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737463

Locations
Korea, Republic of
Institute for Digestive Research, Digestive Disease center, Department of Internal Medicine, Soonchunhyang University College of Medicine
Yongsan-gu, Seoul, Korea, Republic of, 140-743
Sponsors and Collaborators
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.
  More Information

No publications provided

Responsible Party: Byung Hoo Lee, SoonchunhyangUH, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01737463     History of Changes
Other Study ID Numbers: MD-2012-04
Study First Received: November 16, 2012
Last Updated: December 1, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Soonchunhyang University Hospital:
Ampulla of Vater adenoma

Additional relevant MeSH terms:
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014