Clinical Trial: Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Comparative Study of Papillectomy

Brief Summary: Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.

Detailed Summary:

While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy.

In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.


Sponsor: Soon Chun Hyang University

Current Primary Outcome: complete resection [ Time Frame: one month ]

Following endoscopic papillectomy, complete resection will be estimated by pathologic examination


Original Primary Outcome: Same as current

Current Secondary Outcome: complication [ Time Frame: within 24 hours ]

Immediate complications after papillecotmy Delayed complications during 24 hours


Original Secondary Outcome: Same as current

Information By: Soon Chun Hyang University

Dates:
Date Received: March 25, 2014
Date Started: January 2014
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015