A prospective multicenter study of submucosal injection to improve endoscopic snare papillectomy for ampullary adenoma
- Abstract
- BACKGROUND AND AIMS: Whether or not submucosal injection of a diluted epinephrine solution should be used to lift ampullary tumors during endoscopic snare papillectomy is unclear. This study aimed to investigate the clinical efficacy of a simple snaring method versus submucosal injection for papillectomy. METHODS: A prospective multicenter study was performed at 4 tertiary referral centers. Patients with papillary lesions were randomized to undergo either simple snare papillectomy (SSP) or submucosal injection papillectomy (SIP) using 1:10,000 diluted epinephrine. The main outcome measures were complete resection rate and post-papillectomy adverse events. RESULTS: A total of 50 patients with biopsy-proven papillary adenomas were enrolled. Complete resection rates in the SSP and SIP groups were 80.8% (21/26) and 50.0% (12/24), respectively (P= .02). However, tumor persistence at 1 month (15.4% vs 8.3%, P= .62) and recurrence at 12 months (12.0% vs 9.5%, P= .58) did not differ despite initial differences in the prevalence of a positive resection margin. The mean tumor size was 12mm in the SSP group and 9.29mm in the SIP group. Post-papillectomy bleeding developed in 42.3% (11/26) and 45.8% (11/24) of patients, respectively (P= .80). Delayed bleeding (>12 h) occurred in 27.3% (3/11) and 36.4% (4/11) of patients, respectively (P= .50). Post-procedure pancreatitis occurred in 15.4% (4/26) and 25% (6/24) of patients, respectively (P= .49). Pancreatitis severity did not differ between the groups, and there were no procedure-related mortalities. CONCLUSIONS: Although the recurrence rate was similar between the SSP and SIP groups, SIP showed no advantage over SSP in terms of achieving complete resection or decreasing the frequency of post-papillectomy adverse events, such as bleeding. SSP may thus be a simpler and primarily recommendable technique. (Clinical trial registration number: NCT02165852.).
- All Author(s)
- J. J. Hyun
; T. H. Lee
; J. S. Park
; J. H. Han
; S. Jeong
; S. M. Park
; H. S. Lee
; J. H. Moon
; S. H. Park
- Issued Date
- 2017
- Type
- Article
- Keyword
- Adenoma/pathology/*surgery; Aged; Ampulla of Vater/*surgery; Common Bile Duct Neoplasms/pathology/*surgery; Endoscopy, Digestive System/*methods; Female; Humans; Injections; Male; Middle Aged; Pancreatitis/epidemiology; Postoperative Complications/epidemiology; Postoperative Hemorrhage/epidemiology; Prospective Studies; Republic of Korea; Single-Blind Method; Tumor Burden
- Publisher
- American Society for Gastrointestinal Endoscopy
- ISSN
- 0016-5107
- Citation Title
- Gastrointestinal Endoscopy
- Citation Volume
- 85
- Citation Number
- 4
- Citation Start Page
- 746
- Citation End Page
- 755
- Language(ISO)
- eng
- DOI
- 10.1016/j.gie.2016.08.013
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/2780
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