Prospective comparative study of endoscopic papillectomy for ampullary tumor

Prospective comparative multicenter study of wire-guided papillectomy vs. conventional papillectomy for tumors of the duodenal major papilla: pilot study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000869

Enrollment

Registered

2013-10-01

Start date

2012-01-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Conventional endoscopic papillectomy (groua A) is performed using a duodenoscope with a working channel of 3.2 mm (JF-260

Olympus Optical Co, Tokyo, Japan) and a monofilament polypectomy snare (SD-7P-1

Olympus) without an injection of saline solution. After snare resection, a 5-Fr Zimmon stent 5 cm long is routinely placed into the pancreatic duct without prior sphincterotomy. In wire-guided endosco

Microvasive Endosscopy, Boston Scientific Corp, Natick, Mass) is inserted through the catheter and deep into the main pancreatic duct. After removing the ERCP catheter, the loop of an electrosurgical

Olympus) is passed over the guidewire, in monorail fashion, and the snare was closed lightly. After placing the tip of the duodenoscope on the tumor, the snare is deployed so that it grasped the base

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Endoscopically accessible ampullary adenomas with the absence of intraductal growth in the bile duct and the pancreatic duct. 2. Patients refuse a surgical treatment in case of ampullary tumor with focal carcinoma change

Exclusion criteria

Exclusion criteria: 1. Prepapillectomy diagnosis of a malignant tumor 2. Metastatic tumor 3. Coagulopathy

Design outcomes

Primary

Measure	Time frame
Success rate for insertion of pancreatic stent;Complete resection rate	—

Secondary

Measure	Time frame
Tumor recurrence	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Koog Cheon

Konkuk University Medical Center

Outcome results