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Completed

NCT Number: NCT02165852

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

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.

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Key information

Conditions

Ampulla of Vater Adenoma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ampulla of Vater adenoma
  • no uncontrolled coagulopathy

Exclusion criteria

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

Treatment and study plan

Papillectomy without injection

Procedure

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

Papillectomy with injection

Procedure

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

Primary outcomes

  1. complete resection

    Time frame: one month

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

Secondary outcomes

  1. complication

    Time frame: within 24 hours

    Immediate complications after papillecotmy Delayed complications during 24 hours

Sponsors and collaborators

Lead sponsor

Soon Chun Hyang University

Other

Registry information

Official study title

A Prospective Comparative Study of Papillectomy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2014
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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