NCT02165852

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

A Prospective Comparative Study of Papillectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Soon Chun Hyang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Ampulla of Vater Adenoma

Interventions

Type	Name	Description
PROCEDURE	Papillectomy without injection	Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.
PROCEDURE	Papillectomy with injection	Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-06-18
• Last updated: 2015-10-15

Locations

1 site across 1 country: South Korea