Gastric CancerNCT04481828
Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer
An observational study of Gastric Cancer, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer.
Who may be able to join
- Gastric cancer(adenocarcinoma) proven biopsy
- Operated by same surgical team
- Presence of distant metastasis
Who cannot join
- Patients who underwent palliative resection
- operated by a different surgical team
- ASA score: 4
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Derince Training and research Hospital
Kocasinan, Derince, 41900
About this study
Official title: Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center
In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. In this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in Turkey.
Read the detailed description
The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical staging was done using contrast computed tomography (CT). Positron emission tomography (PET) was used in patients with suspected metastasis.The patients were divided into two groups according to the technique applied (open, laparotomy). The first group (Group 1; n: 30) consisted of patients who underwent open surgery, and the second group (Group 2, n: 30) laparoscopic surgery.
- Conditions
- Gastric Cancer
- Being tested
- gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrectomyProcedure or surgery
gastric resection with lymph node dissection(D1+,D2) for stomach cancer.
| Study group | Role | What they receive |
|---|---|---|
| open gastrectomy | The first group (Group 1; n: 30) consisted of patients who underwent open surgery Receives: Procedure: gastrectomy | |
| laparoscopic gastrectomy | The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy Receives: Procedure: gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
year
Measured: 2014-2019
Body mass index
kg/m2
Measured: 2014- 2019
Previous abdominal surgery status
yes or no
Measured: 2014-2019
Comorbidity status
present or absent
Measured: 2014 -2019
Neoadjuvant therapy status
present or absent
Measured: 2014-2019
American Society of Anesthesiologists (ASA) score
1,2,3,4
Measured: 2014-2019
Gender
male or female
Measured: 2014-2019
Surgical technique
open or laparoscopic
Measured: 2014-2019
Tumor localization
proximal, middle, lower
Measured: 2014 - 2019
Gastrectomy type
total, subtotal
Measured: 2014 - 2019
Lymph node dissection type
D1+, D2
Measured: 2014 - 2019
Operation time
minute
Measured: 2014 - 2019
Blood loss
ml
Measured: 2014 - 2019
Complication (Clavien-Dindo Classification)
1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)
Measured: 2014 - 2019
30-day mortality
present or absent
Measured: 2014 - 2019
Number of harvested lymph node
number
Measured: 2014 - 2019
Resection margin status
positive or negative
Measured: 2014 - 2019
Tumor stage (American Joint Committee on Cancer 8th Edition)
0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)
Measured: 2014 - 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study startJan 2014
- Primary completionDec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Yuksel, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481828
- Sponsor's protocol ID
- 2019-98
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okabe H, Tsunoda S, Obama K, Tanaka E, Hisamori S, Shinohara H, Sakai Y. Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04). Ann Surg Oncol. 2016 Aug;23(Suppl 4):516-523. doi: 10.1245/s10434-016-5383-0. Epub 2016 Jul 11.
PubMed 27401443van der Wielen N, Straatman J, Cuesta MA, Daams F, van der Peet DL. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature. Gastric Cancer. 2018 Jan;21(1):19-30. doi: 10.1007/s10120-017-0747-0. Epub 2017 Jul 20.
PubMed 28730391Haverkamp L, Ruurda JP, Offerhaus GJ, Weijs TJ, van der Sluis PC, van Hillegersberg R. Laparoscopic gastrectomy in Western European patients with advanced gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):110-5. doi: 10.1016/j.ejso.2015.09.018. Epub 2015 Oct 22.
PubMed 26603678
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center
- ClinicalTrials.gov ID
- NCT04481828
- Acronym / sponsor ID
- 2019-98
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. In this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in Turkey.
Detailed description
The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical staging was done using contrast computed tomography (CT). Positron emission tomography (PET) was used in patients with suspected metastasis.The patients were divided into two groups according to the technique applied (open, laparotomy). The first group (Group 1; n: 30) consisted of patients who underwent open surgery, and the second group (Group 2, n: 30) laparoscopic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open gastrectomy | – | Procedure: gastrectomyThe first group (Group 1; n: 30) consisted of patients who underwent open surgery |
| laparoscopic gastrectomy | – | Procedure: gastrectomyThe second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer.
Key inclusion criteria (3 listed)
- Gastric cancer(adenocarcinoma) proven biopsy
- Operated by same surgical team
- Presence of distant metastasis
Key exclusion criteria (3 listed)
- Patients who underwent palliative resection
- operated by a different surgical team
- ASA score: 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrectomygastric resection with lymph node dissection(D1+,D2) for stomach cancer. | Procedure or surgery | laparoscopic gastrectomy, open gastrectomy |
Primary outcome
Age
Time frame: 2014-2019
year
Body mass index
Time frame: 2014- 2019
kg/m2
Previous abdominal surgery status
Time frame: 2014-2019
yes or no
Comorbidity status
Time frame: 2014 -2019
present or absent
Neoadjuvant therapy status
Time frame: 2014-2019
present or absent
American Society of Anesthesiologists (ASA) score
Time frame: 2014-2019
1,2,3,4
Gender
Time frame: 2014-2019
male or female
Surgical technique
Time frame: 2014-2019
open or laparoscopic
Tumor localization
Time frame: 2014 - 2019
proximal, middle, lower
Gastrectomy type
Time frame: 2014 - 2019
total, subtotal
Lymph node dissection type
Time frame: 2014 - 2019
D1+, D2
Operation time
Time frame: 2014 - 2019
minute
Blood loss
Time frame: 2014 - 2019
ml
Complication (Clavien-Dindo Classification)
Time frame: 2014 - 2019
1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)
30-day mortality
Time frame: 2014 - 2019
present or absent
Number of harvested lymph node
Time frame: 2014 - 2019
number
Resection margin status
Time frame: 2014 - 2019
positive or negative
Tumor stage (American Joint Committee on Cancer 8th Edition)
Time frame: 2014 - 2019
0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Background: PubMed 27401443Okabe H, Tsunoda S, Obama K, Tanaka E, Hisamori S, Shinohara H, Sakai Y. Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04). Ann Surg Oncol. 2016 Aug;23(Suppl 4):516-523. doi: 10.1245/s10434-016-5383-0. Epub 2016 Jul 11.
- Background: PubMed 28730391van der Wielen N, Straatman J, Cuesta MA, Daams F, van der Peet DL. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature. Gastric Cancer. 2018 Jan;21(1):19-30. doi: 10.1007/s10120-017-0747-0. Epub 2017 Jul 20.
- Background: PubMed 26603678Haverkamp L, Ruurda JP, Offerhaus GJ, Weijs TJ, van der Sluis PC, van Hillegersberg R. Laparoscopic gastrectomy in Western European patients with advanced gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):110-5. doi: 10.1016/j.ejso.2015.09.018. Epub 2015 Oct 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: 2014-2019). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481828, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.