UMIN-CTR Clinical Trial

Public title

Short- and Long-term outcomes of robotic gastrectomy for gastric cancer: multi-institutional retrospective study

Acronym

Robotic gastrectomy

Scientific Title

Short- and Long-term outcomes of robotic gastrectomy for gastric cancer: multi-institutional retrospective study

Scientific Title:Acronym

Robotic gastrectomy

Region

Japan

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the safety, feasibility, and effectiveness of robotic gastrectomy (RG) for gastric cancer (GC) and compare the findings to those of conventional laparoscopic gastrectomy (LG)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

3-year OS

Key secondary outcomes

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who met the following criteria were included: operable under general anesthesia; histologically proven gastric adenocarcinoma; cStage I or II disease not indicated for endoscopic resection according to the Japanese Gastric Cancer Treatment Guidelines; curably treated with total, distal, or proximal gastrectomy involving D1+ or D2 lymph node dissection; age over 18 years.

Key exclusion criteria

Patients who met the following criteria were excluded: preoperative use of chemotherapy and presence of mental disorders.

Target sample size

1127

Name of lead principal investigator

1st name	Ichiro
Middle name
Last name	Uyama

Organization

Fujita Health University

Division name

Gastroenterological Surgery

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi

TEL

0562-93-9254

Email

iuyama@fujita-hu.ac.jp

Name of contact person

1st name	Suda
Middle name
Last name	Koichi

Organization

Fujita Health University

Division name

Gastroenterological Surgery

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi

TEL

0562-93-9254

Homepage URL

Email

ko-suda@fujita-hu.ac.jp

Institute

Fujita Health University

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Saga University, Kyoto University

Name of secondary funder(s)

Organization

Institutional Review Board of Fujita Health University

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi

Tel

0562-93-2865

Email

f-irb@fujita-hu.ac.jp

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

2018

Year

11

Month

01

Day

URL releasing protocol

N/A

Publication of results

Published

URL related to results and publications

N/A

Number of participants that the trial has enrolled

1127

Results

Of the 1,127 patients in the previous study, 326 and 752 patients in the RG and LG groups, respectively, completed the study. In the weighted population, 3yOS was 96.3% and 89.6% in the RG and LG groups, respectively (hazard ratio [HR], 0.34 [0.15, 0.76]; p = 0.009), whereas there was no difference in three-year recurrence-free survival rate (3yRFS) between the two groups (HR, 0.58 [0.32, 1.05]; p = 0.073). Sub-analyses showed that RG improved 3yOS and 3yRFS in patients with pStage IA disease.

Results date posted

2022

Year

04

Month

06

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The RG group comprised 326 patients from 15 institutions who prospectively underwent RG between October 2014 and January 2017 in a previous study (UMIN000015388), approved for Advanced Medical Technology ("Senshiniryo") B, in which patients are requested to pay for the designated technology. The LG group consisted of the historical controls of that study, which included 801 patients from three institutions (338, 248, and 215 patients from Fujita Health University, Saga University, and Kyoto University, respectively) who underwent insured LG between 2009 and 2012.

Participant flow

A total of 1,127 patients (326 in the RG group and 801 in the LG group) were enrolled in this study. We excluded 44 patients, all in the LG group, from the analysis set because they had multiple primary cancers (n = 38), special histological types (n = 3), cStage III or greater, or unknown disease (n = 2), and duplicate records (n = 1). Thus, the full analysis set comprised 326 patients in the RG group and 757 in the LG group.

Adverse events

Apart from the unweighted group, RG did not improve morbidity rate in the weighted group (RG, 3.7% vs. LG, 5.0%). A similar trend was observed in the incidence of intra-abdominal infectious complications (RG, 2.4% vs. LG, 4.1%). RG attenuated some of the adverse events, including anastomotic leakage (RG, 0.2% vs. LG, 2.2%) and intra-abdominal abscess (RG, 0.0% vs. LG, 1.6%). However, there was no difference between the RG and LG groups in terms of pancreatic fistula (RG, 2.2% vs. LG, 0.9%). Although pulmonary complications, sepsis, renal complications, anastomotic stenosis/passage obstruction, gastrointestinal bleeding, and in-hospital mortality seemed to be attenuated, and intra-abdominal bleeding seemed to be increased in the RG group, the numbers of these events were too small to determine practical significance.
Although RG increased medical costs and surgical costs, it improved estimated blood loss and duration of postoperative hospitalization. No differences were observed between the RG and LG groups in terms of operative time, number of dissected lymph nodes, and conversion to open surgery.

Outcome measures

The primary outcome measure was three-year overall survival rate (3yOS).
The secondary outcomes were three-year recurrence free survival rate (3yRFS); recurrence rate within three years of surgery; pattern of recurrence (local, reginal lymphatic, distant lymphatic, peritoneal, hepatic, pulmonary, skin, bone marrow, bone, pleural, brain, meningeal, adrenal, muscles of the abdominal wall, and others); surgical outcomes, including operative time, estimated blood loss, and number of dissected lymph nodes; open surgery conversion rate; duration of postoperative hospitalization; total medical cost, including the operative fee and perioperative admission expense; cost per surgical procedure; morbidity rate within 30 days after surgery (C-D Grade IIIa or greater); incidence of each postoperative complication, including systemic complications (cardiovascular, pulmonary, sepsis, renal, hepatic, gastrointestinal, central nervous system, peripheral nervous system, and others) and local complications (intra-abdominal infectious complications, including anastomotic leakage, pancreatic fistula, and intra-abdominal abscess; anastomotic stenosis/obstruction in food passage; delayed gastric emptying; wound infection; bowel obstruction; intra-abdominal bleeding; gastrointestinal bleeding; internal hernia; and others); in-hospital mortality after surgery; and reoperation rate within three years after surgery.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2018

Year

09

Month

28

Day

Date of IRB

2018

Year

12

Month

25

Day

Anticipated trial start date

2018

Year

12

Month

26

Day

Last follow-up date

2021

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2021

Year

03

Month

31

Day

Other related information

Short- and Long-term outcomes will be compared between the 326 patients who underwent robotic gastrectomy in the UMIN000015388 study and the 801 patients who underwent conventional laparoscopic gastrectomy (the historical control group in the UMIN00001538 study).

Registered date

2018

Year

10

Month

03

Day

Last modified on

2023

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039173