UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000021200
Receipt number	R000024449
Scientific Title	Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum
Date of disclosure of the study information	2016/03/01
Last modified on	2019/02/25 14:10:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum

Acronym

Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum

Scientific Title

Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum

Scientific Title:Acronym

Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum

Region

Japan

Condition

Duodenal adenoma, duodenal mucosal cancer, duodenal NET, duodenal SMT

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Evaluation of in laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Assessment

Primary outcomes

Postoperative one-week complication rates in laparoscopy endoscopy hybrid surgery

Key secondary outcomes

Surgical process (operative time, intraoperative bleeding, the number of ports, the use of the saturation, cost, the rates of laparotomy transition), postoperative course (oral intake, length of stay, inflammatory findings, the rates of late complications, stenosis).

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Hybrid endoscopic and laparoscopic partial duodenectomy for low malignant tumor of duodenum.
Closing the site of duodenectomy by laparoscopic hand-sewn saturation.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Duodenal adenoma, duodenal mucosal cancer (adenocarcinoma), duodenal NET (less than 20 mm, longer axis), duodenal SMT (less than 50 mm, longer axis)
2)Intraluminal developmental form of SMT
3)Performance status o and 1
4)Plt => 100,000/mm3
Creatinine <= 2.0 mg/dl
AST <= 200 IU/L
ALT <= 200 IU/L
T-bil <= 2.0 mg/dl
Hb => 8.0 g/dl
5)Patients who gave written informed consent before entry in this study

Key exclusion criteria

1)Ischemic heart disease
2)Liver cirrhosis, active hepatitis
3)Interstitial pneumonia
4)Haemodialysis
5)Both malignant disorder
6)Severe abdominal adhesion
7)Doctor's decision not to register to this regimen

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Toshiyasu Ojima

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

Kimiidera 811-1, Wakayama, Japan

TEL

073-441-0613

Email

tojima@wakayama-med.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Toshiyasu Ojima

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

Kimiidera 811-1, Wakayama, Japan

TEL

073-441-0613

Homepage URL

Email

tojima@wakayama-med.ac.jp

Sponsor or person

Institute

Second Department of Surgery, Wakayama Medical University, School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Second Department of Surgery, Wakayama Medical 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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

和歌山県立医科大学附属病院

Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 01 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29352442

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

Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 02 Month 10 Day

Date of IRB

Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2016 Year 02 Month 25 Day

Last modified on

2019 Year 02 Month 25 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024449

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name