UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029227
Receipt number R000033408
Scientific Title A randomized study of a 3D-HD or a 2D-4K laparoscopic surgery for gastric cancer.
Date of disclosure of the study information 2017/11/01
Last modified on 2021/10/07 17:43:33

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Basic information

Public title

A randomized study of a 3D-HD or a 2D-4K laparoscopic surgery for gastric cancer.

Acronym

Laparoscopic surgery for gastric cancer (3D-HD vs 2D-4K)

Scientific Title

A randomized study of a 3D-HD or a 2D-4K laparoscopic surgery for gastric cancer.

Scientific Title:Acronym

Laparoscopic surgery for gastric cancer (3D-HD vs 2D-4K)

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the usefulness of a 3D-HD laparoscopy for laparoscopic gastrectomy compared to a 2D-4K laparoscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

The operative time (Overall operative time, Partly operative time for each technical part)

Key secondary outcomes

A number of dissected lymph nodes, Blood loss, A number of bleeding, The rate of infectious complication (pancreatic fistula, abdominal abscess), The postoperative days


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

3D-HD laparoscopy (1 year)

Interventions/Control_2

2D-4K laparoscopy (1 year)

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

1) Pathologically diagnosed as gastric cancer
2) T1-T4aN0 or T1-T1aN(+) according to Japanese Classification of Gastric Carcinoma the 14th edition. (N(+) as N1 according to Japanese Classification of Gastric Carcinoma the 13th edition.)
3) Indication of curative resection by distal gastrectomy or total gastrectomy
4) No invading the esophagus or duodenum.
5) 20 years-old or above, 79 years-old or below
6) Performance status (ECOG) 0 or 1
7) BMI(Body mass index) <30
8) The most recent blood examination satisfies following items:
(1) WBC: 3,000/mm3 or above
(2) PLT: 100,000/mm3 or above
(3) T-BIL: 2.0 mg/dL or below
(4) AST(GOT): 100 IU/L or below
(5) ALT(GPT): 100 IU/L or below
(6) CRE: 1.5 mg/dL or below
9) Getting informed consent from the patient in writing

Key exclusion criteria

1) Infectious disease required systemic therapy
2) Body temperature: 38 degrees or above
3) Pregnant, possibility in pregnancy, Within postpartum 28 days or lactating
4) Difficult to cooperate in the trial for psychiatric reasons
5) Administration of steroids or immunosuppressants
6) History of unstable angina pectoris or within six month after acute myocardial infarction
7) Uncontrolled hypertension
8) Uncontrolled diabetes regardless of administration of insulin
9) Respiratory disease receiving continuous oxygen inhalation
10) Surgery for remnant gastric cancer, esophagogastric junction cancer or another simultaneous disease (without cholecystectomy)

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Shingo
Middle name
Last name Kanaji

Organization

Graduate School of Medicine, Kobe University

Division name

Division of Gastroenterology, Department of Surgery

Zip code

6500017

Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo

TEL

078-382-5925

Email

kanashin@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Hitoshi
Middle name
Last name Harada

Organization

Graduate School of Medicine, Kobe University

Division name

Division of Gastroenterology, Department of Surgery

Zip code

6500017

Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo

TEL

078-382-5925

Homepage URL


Email

htharada@med.kobe-u.ac.jp


Sponsor or person

Institute

Division of Gastroenterology, Department of Surgery, Graduate School of Medicine, 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 Institutional Review Board

Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo

Tel

078-382-5925

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

神戸大学医学附属病院


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 01 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34458930/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34458930/

Number of participants that the trial has enrolled

42

Results

There were no significant differences in surgical outcomes between the two groups. However, video analysis of surgeries revealed a significantly shortened median operative time (18 vs. 25 min, P=0.04) in the suturing step with 3-D/HD; the median number of camera cleaning procedures during suprapancreatic lymph node dissection was significantly lower with 2-D/4 K than with 3-D/HD (n=4.4 vs. 2.8, P=0.02).

Results date posted

2021 Year 10 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The patients were diagnosed as gastric cancer and considered to be performed laparoscopic gastrectomy for curative resection in our institution, from April 2018 to August 2019.

Participant flow

50 patients were randomly classified into two groups based on the imaging technology (3-D/HD group=25, 2-D/4 K=25). After excluding eight patients based on laparoscopic findings, 42 patients were analyzed (3-D/HD group=21, 2-D/4 K=21).

Adverse events

There were three cases in the 3D/HD group and six cases in the 2D/4K group with postoperative complications of grade II or higher according to the Clavien-Dindo classification.

Outcome measures

The primary study endpoint was the operative time (overall operative time, partial operative time for each technical step). In contrast, the secondary endpoints were the number of dissected lymph nodes, blood loss, the amount of bleeding, incidence rate of postoperative infectious complications (pancreatic fistula and abdominal abscess), and postoperative hospital stay. Postoperative morbidity was described according to the Clavien-Dindo classification.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 09 Month 21 Day

Date of IRB

2018 Year 03 Month 30 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 21 Day

Last modified on

2021 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033408


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name