UMIN-CTR Clinical Trial

Public title

Evaluation of safety and efficacy of laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor

Acronym

Evaluation of safety and efficacy of LECS for duodenal tumor

Scientific Title

Evaluation of safety and efficacy of laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor

Scientific Title:Acronym

Evaluation of safety and efficacy of LECS for duodenal tumor

Region

Japan

Condition

duodenal adenoma, eraly duodenal cancer, duodenal GIST, duodenal carcinoid

Classification by specialty

Medicine in general	Gastroenterology	Surgery in general
Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of safety in laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Evaluation of postoperative complication rates in LECS, in comparison with previous reported complication rates following simple endoscopic resection in duodenal tumor

Key secondary outcomes

Evaluation of pancereatoduodenectomy (PD) rates due to postoperative complications following LECS, in comparison with previous reported PD rates due to complications following simple endoscopic resection in duodenal tumor

Study type

Observational

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

Inclusion criteria
1. Preoperative diagnosis is confirmed as a duodenal adenoma, early duodenal cancer, duodenal GIST and duodenal carcinoid.
2. Tumors located from bulbs to lower portion of duodenum
3. Age of more than 20 years old at
4. Performance status 0, 1 and 2
5. Fulfill all below criterion
Hb =>9 g/dl
Plt=>100,000/mm3
AST or ALT <=100 lU/l
Serum creatinine<=2.0 mg/dl
PT-INR% =>80%
6. Patients who could be followed during 56 days
7. Patients who agree the content of this study

Key exclusion criteria

Exclusion criteria
1. Patients who could not agree the content of this study.
2. Residual tumor following endoscopic resection
3. Totally of sub circumferential tumor
4. Tumors located in Ampulla of Vater
5. Tumors which the surface is near the pancreas
6. Post radiation therapy
7. Severe abdominal adhesion
8. Patients who are pregnant
9. Patients who have a psychiatric disorder
10. Patients who have active infectious or fungal disease
11. Severe hypertension
12. Severe respiratory disease
13. Patients that researchers admit inadequate for candidates

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Eigo Otsuji

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery, Department of Surgery

Zip code

Address

Kyoto Prefectural University of Medicine, 465 Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan

TEL

(+81)75-251-5527

Email

otsuji@koto.kpu-m.ac.jp

Name of contact person

1st name
Middle name
Last name	Shuhei Komatsu

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery, Department of Surgery

Zip code

Address

Kyoto Prefectural University of Medicine, 465 Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Jap

TEL

(+81)75-251-5527

Homepage URL

Email

skomatsu@koto.kpu-m.ac.jp

Institute

Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine

Institute

Department

Personal name

Organization

Digestive Surgery Donation 1

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2015

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015

Year

11

Month

10

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

As a recruiting method of patients, we will recruit all patients who meet our study criteria since November 20, 2015.

Registered date

2015

Year

10

Month

19

Day

Last modified on

2016

Year

03

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022447