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

Soon Chun Hyang University

Status and phase: Completed; Phase 3

Conditions: Ampulla of Vater Adenoma

Treatments: Procedure: Papillectomy without injection; Procedure: Papillectomy with injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02165852

Papillectomy Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ampulla of Vater adenoma
• no uncontrolled coagulopathy

Exclusion criteria

• adenocarcinoma of ampulla of Vater
• uncontrolled coagulopathy
• refusal to this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Papillectomy without injection

Experimental group

Description:

Conventional snaring mucoal resection without submucosal injection

Treatment:

Procedure: Papillectomy without injection

Papillectomy with injection

Active Comparator group

Description:

Conventional mucosal resction method following injeciton of diluted epinephrine mixture.

Treatment:

Procedure: Papillectomy with injection