UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019208
Receipt number R000020255
Scientific Title Safety of Laparoscopic-endoscopic cooperative surgery for duodenal tumor.
Date of disclosure of the study information 2015/10/10
Last modified on 2020/07/09 14:01:10

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Basic information

Public title

Safety of Laparoscopic-endoscopic cooperative surgery for duodenal tumor.

Acronym

Safety of LECS for duodenal tumor.

Scientific Title

Safety of Laparoscopic-endoscopic cooperative surgery for duodenal tumor.

Scientific Title:Acronym

Safety of LECS for duodenal tumor.

Region

Japan


Condition

Condition

duodenal tumor

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the safety of laparoscopic-endoscopic cooperative surgery for duodenal tumor.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence rate of anastomotic leakage of the duodenum within one month after operation.

Key secondary outcomes

The incidence rate of adverse event (Clavien-Dindo classification, GradeII and higher) and operation related death within one month after opeartion, and proportion of conversion to open surgery


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic-endoscopic cooperative surgery

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

For inclusion in the study, patients must fulfill the following requirements preoperatively:
1) duodenal tumor is 5 cm or smaller and difficult having en-bloc resection by endoscopic mucosal resection.
2) Aged 20 to 80 year
3) PS (ECOG)0 or 1
4) provided written informed consent

Key exclusion criteria

1) no history of gastrointestinal surgery except appendectomy due to appendicitis.
2) no history of chemotherapy or radiotherapy.
3) all laboratory data must fulfill the following requirements within 56 days prior to trial registration.
1. white blood cell count; 3,000/mm3 or more
2. blood platelet count; 100,000/mm3 or more
3. Aspartate Aminotransferase; 100 IU/L or lower
4. Alanine aminotransferas; 100 IU/L or lower
5. total bilirubin; 2.0 mg/dL or lower
6. creatinine; 1.5 mg/dL or lower
4) without informed consent
5) patients who were judged inadequate by clinical trial principal investigator or subinvestigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shingo
Middle name
Last name Kanaji

Organization

Kobe University

Division name

Gastrointestinal Surgery

Zip code

6500017

Address

Kusunoki-chou 7-5-2, Chuo-ku, Kobe

TEL

078-382-5925

Email

kanashin@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Shingo
Middle name
Last name Kanaji

Organization

Kobe University

Division name

Gastrointestinal Surgery

Zip code

6500017

Address

Kusunoki-chou 7-5-2, Chuo-ku, Kobe

TEL

078-382-5925

Homepage URL


Email

kanashin@med.kobe-u.ac.jp


Sponsor or person

Institute

Gastrointestinal Surgery, Kobe University

Institute

Department

Personal name



Funding Source

Organization

None

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

Kobe University Hospital CTRC

Address

Kobe University Hospital CTRC

Tel

078-382-6515

Email

kainyu@med.kobe-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

神戸大学病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 10 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020255

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1111/den.13705

Number of participants that the trial has enrolled

20

Results

Sixteen tumors were located in the second portion, three in the first portion, and one in the third portion of the duodenal region. The median operative time was 225 (134-361) min and the median blood loss was 0 (0-150) mL. Curative resection (R0) with negative margins was achieved in 19 cases.The median duration of postoperative hospital stay was 9 (5-12) days.

Results date posted

2020 Year 07 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 04 Month 25 Day

Baseline Characteristics

Between January 2015 and September 2018, 20 eligible patients were enrolled.

Participant flow

Patients participated this study when their written consent has been obtained.

Adverse events

One case of postoperative leakage and one case of bleeding of grade 2 according to the Clavien-Dindo classification were observed in this series.

Outcome measures

No local recurrence was observed in any patient during the median follow-up of 15.0 (12.0-38.0) months.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 09 Month 24 Day

Date of IRB

2015 Year 09 Month 24 Day

Anticipated trial start date

2015 Year 10 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2030 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 02 Day

Last modified on

2020 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name