UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040288 |
|---|---|
| Receipt number | R000045964 |
| Scientific Title | Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2026/05/05 12:52:22 |
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Basic information
Public title
Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Acronym
Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Scientific Title
Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Scientific Title:Acronym
Multicenter retrospective study in endoscopic papillectomy for duodenal ampullary tumor
Region
| Japan |
Condition
Condition
Ampullary tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, prognosis, and treatment of endoscopic papillectomy (EP).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success rate of EP
Key secondary outcomes
1. Comparison of preoperative biopsy (biopsy site and number of biopsies) and postoperative pathology.
2. Primary disease, length of stay and cost of hospitalization.
3. Long-term postoperative recurrence rate and recurrence pattern.
4. Relationship between procedures of EMR and procedure related complications.
5. Relationship between prophylactic method and procedure related complications.
Base
Study type
Observational
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 have endoscopic papillectomy.
Key exclusion criteria
None.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Iwasaki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3790
e-iwa@keio.jp
Public contact
Name of contact person
| 1st name | Atsuto |
| Middle name | |
| Last name | Kayashima |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3790
Homepage URL
kayashima@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine IRB
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
+81-3-5363-3790
kayashima@keio.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
東京医科大学 臨床医学系消化器内科学分野（東京）、慶應義塾大学医学部消化器内科（東京）、みやぎ健診プラザ（宮城）、藤田医科大学 ばんたね病院（名古屋）、福岡大学筑紫病院（福岡）、東邦大学医療センター大森病院（東京）、埼玉医科大学国際医療センター（埼玉）、手稲渓仁会病院 消化器病センター（北海道）、名古屋大学大学院医学系研究科（愛知）、鹿児島大学病院（鹿児島）、順天堂大学医学部附属順天堂医院（東京）、岡山大学病院（岡山）、神戸大学医学部附属病院（兵庫）、自治医科大学附属病院（栃木）、獨協医科大学病院（栃木）、長崎大学病院（長崎）、聖マリアンナ医科大学病院（神奈川）、北里大学病院（神奈川）、愛知がんセンター（愛知）、九州大学病院（福岡）、横浜市立大学付属病院（神奈川）、東京大学病院（東京）、大阪がんセンター（大阪）、佐世保市総合医療センター（長崎）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.giejournal.org/article/S0016-5107(25)02133-9/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.giejournal.org/article/S0016-5107(25)02133-9/fulltext
Number of participants that the trial has enrolled
875
Results
798 had confirmed ampullary epithelial tumor, and 776 were included in the long-term outcome analysis. The 3-year cumulative recurrence rate was 20%. Indeterminate (Rx) and positive (R1) resection margins were independently associated with higher recurrence compared with negative margins (R0), with hazard ratios of 2.30 (95% CI, 1.44-3.68) and 2.95 (95% CI, 1.85-4.71), respectively. R0 resection was achieved in 52.1% (416/798) of patients, with a 3-year cumulative recurrence rate of 11% (95% CI, 7.6%-15%).
Results date posted
| 2026 | Year | 05 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 10 | Month | 26 | Day |
Baseline Characteristics
Between 2009 and 2020, 776 patients received EP at 22 tertiary medical institutions in Japan.
Participant flow
In a retrospective study using opt-out, patients who underwent EP treatment were enrolled.
Adverse events
NoneAdverse events occurred in 32.5% (259/798) of patients, with the most common delayed bleeding (19.4%) and pancreatitis (13.8%) (Table 4). Severe adverse events occurred in 3.9% of patients. One treatment-related death (0.1%) was reported in a patient with cirrhosis who died from liver failure after delayed postprocedural bleeding.
Outcome measures
he primary outcome is cumulative recurrence, and the secondary outcomes are length of hospitalization, adverse events, and retreatment modalities
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
None.
Management information
Registered date
| 2020 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045964
