Skip to content

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

A Prospective Comparative Study of Papillectomy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02165852
Enrollment
50
Registered
2014-06-18
Start date
2014-01-31
Completion date
2015-10-31
Last updated
2015-10-15

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

Conditions

Ampulla of Vater Adenoma

Keywords

ampulla of Vater, adenoma, papillectomy, injection, non-injection

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 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.

Interventions

PROCEDUREPapillectomy with injection

Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.

PROCEDUREPapillectomy without injection

Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.

Sponsors

Soon Chun Hyang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ampulla of Vater adenoma * no uncontrolled coagulopathy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
complete resectionone monthFollowing endoscopic papillectomy, complete resection will be estimated by pathologic examination

Secondary

MeasureTime frameDescription
complicationwithin 24 hoursImmediate complications after papillecotmy Delayed complications during 24 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026