UMIN-CTR Clinical Trial

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

ampullary adenomas and adenocarcinomas

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

long-term prognosis

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Overall survival

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Gastroenterology and Hepatology, Nagasaki University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

08

Month

06

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/33999505/

Publication of results

Published

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

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 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.

Registered date

2019

Year

08

Month

06

Day

Last modified on

2021

Year

08

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042872