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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Papillectomy without injection | Experimental | Conventional snaring mucoal resection without submucosal injection |
|
| Papillectomy with injection | Active Comparator | Conventional mucosal resction method following injeciton of diluted epinephrine mixture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papillectomy without injection | Procedure | Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete resection | Following endoscopic papillectomy, complete resection will be estimated by pathologic examination | one month |
| Measure | Description | Time Frame |
|---|---|---|
| complication | Immediate complications after papillecotmy Delayed complications during 24 hours | within 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Hoon Lee, MD, PhD | Soonchunhyang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Cheonan Hospital | Cheonan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27566056 | Derived | Hyun JJ, Lee TH, Park JS, Han JH, Jeong S, Park SM, Lee HS, Moon JH, Park SH. A prospective multicenter study of submucosal injection to improve endoscopic snare papillectomy for ampullary adenoma. Gastrointest Endosc. 2017 Apr;85(4):746-755. doi: 10.1016/j.gie.2016.08.013. Epub 2016 Aug 24. |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Papillectomy with injection | Procedure | Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection. |
|