UMIN-CTR Clinical Trial

Basic information
Public title	study on safety and long-term prognosis of endoscopic papillectomy for ampullary adenoma and adenocarcinoma
Acronym	safety and long-term prognosis of endoscopic papillectomy for ampullary adenoma and adenocarcinoma
Scientific Title	Retrospective multicenter study on safety and long-term prognosis of endoscopic papillectomy for ampullary adenoma and adenocarcinoma
Scientific Title:Acronym	safety and long-term prognosis of endoscopic papillectomy for ampullary adenoma and adenocarcinoma
Region	Japan

Condition
Condition	ampullary adenomas and adenocarcinomas
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	long-term prognosis
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent endoscopic papillectomy (EP) between January 2000 and October 2018
Key exclusion criteria	Patients who can not obtain demographic data and clinical information used in this study
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Eisuke Middle name Last name Ozawa
Organization	Nagasaki University
Division name	Department of Gastroenterology and Hepatology
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki prefecture, Japan
TEL	0958197481
Email	eisukeozawa@nifty.com

Public contact
Name of contact person	1st name Kosuke Middle name Last name Takahashi
Organization	Nagasaki University
Division name	Department of Gastroenterology and Hepatology
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki prefecture, Japan
TEL	0958197481
Homepage URL
Email	takapochi0809@gmail.com

Sponsor
Institute	Department of Gastroenterology and Hepatology, Nagasaki University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Clinical Research Review Board in Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken,Japan
Tel	095-819-7905
Email	gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 06 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/33999505/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/33999505/
Number of participants that the trial has enrolled	129
Results	The pathological diagnoses of resected specimens confirmed adenoma in 62 and adenocarcinoma in 34 patients . Recurrent lesions were observed in 13 patients (13.5%) during a median follow-up of 3 months after EP. The predictive factors of recurrence were piecemeal resection, and nonnegative horizontal or vertical margin in univariate analysis. Nonnegative vertical margin was the only independent predictive factor of recurrence in the multivariate analysis.
Results date posted	2021 Year 08 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	During the study period, a total of 129 patients underwent EP at the various institutions. However, the pathological diagnoses of the resected specimens were non-neoplastic in 28 patients. The remaining 101 patients were diagnosed with adenoma (N = 62) or adenocarcinoma (N = 39) based on the pathological assessment of the resected specimen. Of the 39 patients with adenocarcinoma, five cases were lost to follow-up after EP.
Participant flow	Overall, a total of 96 patients were included in this follow-up study. The median age of the patients was 69 years , and 49 patients were men. All patients had no history of familial adenomato s polyposis.
Adverse events	Complications occurred in 15 cases (15.7%). The most common complication was bleeding (6.3%), followed by pancreatitis (4.2%), cholangitis (3.1%), and stent migration (2.1%).
Outcome measures	Patient background. Gender, age, drinking history, smoking history, discovery opportunity, medical history, oral history Thrombosis, PPI Blood test findings: Hb, Plt, TP, Alb, T.Bil, D.Bil, Amy, PT, APTT, CEA, CA19-9 Endoscopic findings: treatment date, macroscopic type of tumor, size, presence or absence of ulcer, color tone, Presence or absence of vascular, mucosal atypia, presence , absence of intrabile duct , pancreatic duct extension Presence or absence of preoperative bile duct , pancreatic duct stent insertion Intra-EP findings Pathological findings. Preoperative pathological results, postoperative pathological results Presence , absence of attack, evaluation of excision margin, presence , absence of radical resection), concordance rate of preoperative and postoperative pathological results Complications. Confirmation of complications (bleeding, gastrointestinal perforation, pancreatitis, gallbladder , cholangitis, post-bleeding, post-perforation) and response to complications Recurrence information. Residual , recurrence presence , absence and response, time required for recurrence, recurrence site Survival confirmation. Last survival confirmation date, presence , absence of death, cause of death, date and time of death
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 12 Month 11 Day
Date of IRB	2018 Year 12 Month 11 Day
Anticipated trial start date	2018 Year 12 Month 11 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this study, we used data from patients who had undergone endoscopic papillectomy (EP) between January 2000 and October 2018 at our department and related facilities. This a retrospective multicenter study to analyze the short-term outcome and prognosis.

Management information
Registered date	2019 Year 08 Month 06 Day
Last modified on	2021 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042872