GastrectomyNCT05495217
A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer
A study testing Conventional Laparoscopy and Gasless Laparoscopy in people with Gastrectomy and Laparoscopy, run by Xue Yingwei at 1 site in China.
Trial summary
The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrectomy, Laparoscopy
- What is being tested?
- Conventional Laparoscopy and Gasless Laparoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and <75 years old;
- The gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma [pap], tubular adenocarcinoma [tub], mucinous adenocarcinoma [muc], signet ring cell carcinoma [sig], and poorly differentiated adenocarcinoma [por]);
- Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
- It is expected that R0 surgical results will be obtained by distal subtotal gastrectomy and D2 lymph node dissection (also applies to multiple primary tumors)
- Preoperative ECOG status score of 0/1;
- Preoperative ASA (American society of anesthesiology) class of I -III;
- Patients signed informed consent.
Who cannot join
- Pregnant or lactating women;
- Serious mental illness;
- History of abdominal surgery (except for laparoscopic cholecystectomy);
- History of gastric surgery (including ESD/EMR for gastric cancer);
- Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm)
- Other malignant disease history within five (5) years;
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- Patients who received or were recommended a new adjuvant therapy;
- History of unstable angina or myocardial infarction within six (6) months;
- History of cerebral infarction or cerebral hemorrhage within six (6) months;
- History of sustained systemic corticosteroid therapy within one (1) month;
- Patients requiring simultaneous surgical treatment of other diseases;
- Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;
- Pulmonary function test with FEV1 <50% of the expected value.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Controlled Clinical Study for Comparison of the Effects Between Gasless Laparoscopy-assisted and Conventional Laparoscopy-assisted Gastrectomy With D2 Lymphadenectomy for Distal Gastric Cancer
The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).
Read the detailed description
The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.
- Conditions
- Gastrectomy, Laparoscopy
- Being tested
- Conventional Laparoscopy, Gasless Laparoscopy
- Keywords
- Laparoscopy-assisted Gastrectomy, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional LaparoscopyDevice
Also called Laparoscopic Surgery
A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY using Induced pneumoperitoneum.
Gasless LaparoscopyDevice
Also called Gasless Laparoscopic Surgery
A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY without Induced pneumoperitoneum.It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Gasless Laparoscopy-assisted Gastrectomy | Experimental | Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. Receives: Device: Gasless Laparoscopy |
| Conventional Laparoscopy-assisted Gastrectomy | Other | Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. Receives: Device: Conventional Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy.
Measured: During procedure.
Secondary outcomes (8)
Blood pressure
Intraoperative blood pressure
Measured: Through study completion, an average of 2 year.
End-tidal carbon dioxide
Intraoperative end-tidal carbon dioxide
Measured: Through study completion, an average of 2 year.
Heart rate
Intraoperative heart rate
Measured: Through study completion, an average of 2 year.
Estimated blood loss
Intraoperative estimated blood loss
Measured: Through study completion, an average of 2 year.
Complications
Intraoperative complications
Measured: Through study completion, an average of 2 year.
Death
Intraoperative death
Measured: Through study completion, an average of 2 year.
Blood transfusion
Intraoperative and postoperative blood transfusion
Measured: Through study completion, an average of 2 year.
Tumor size
Tumor size
Measured: Through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Dec 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xue Yingwei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xue Yingwei, The Third Affiliated Hospital of Harbin Medical University
- Investigators
- Yingwei Xue, doctor, Study director, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495217
- Sponsor's protocol ID
- XJS2021-13
- Status last verified
- Aug 2022
- First submitted
- 23 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Controlled Clinical Study for Comparison of the Effects Between Gasless Laparoscopy-assisted and Conventional Laparoscopy-assisted Gastrectomy With D2 Lymphadenectomy for Distal Gastric Cancer
- ClinicalTrials.gov ID
- NCT05495217
- Acronym / sponsor ID
- XJS2021-13
- Conditions
- Gastrectomy, Laparoscopy
- Keywords
- Laparoscopy-assisted Gastrectomy, Gastric cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xue YingweiUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 10 Aug 2022 (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.
The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).
Detailed description
The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gasless Laparoscopy-assisted Gastrectomy | Experimental | Device: Gasless LaparoscopyPatients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. |
| Conventional Laparoscopy-assisted Gastrectomy | Other | Device: Conventional LaparoscopyPatients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 and <75 years old;
- The gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma [pap], tubular adenocarcinoma [tub], mucinous adenocarcinoma [muc], signet ring cell carcinoma [sig], and poorly differentiated adenocarcinoma [por]);
- Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
- It is expected that R0 surgical results will be obtained by distal subtotal gastrectomy and D2 lymph node dissection (also applies to multiple primary tumors)
- Preoperative ECOG status score of 0/1;
Key exclusion criteria (13 listed)
- Pregnant or lactating women;
- Serious mental illness;
- History of abdominal surgery (except for laparoscopic cholecystectomy);
- History of gastric surgery (including ESD/EMR for gastric cancer);
- Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm)
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 |
|---|---|---|
| Conventional LaparoscopyAlso: Laparoscopic SurgeryA procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY using Induced pneumoperitoneum. | Device | Conventional Laparoscopy-assisted Gastrectomy |
| Gasless LaparoscopyAlso: Gasless Laparoscopic SurgeryA procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY without Induced pneumoperitoneum.It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures. | Device | Gasless Laparoscopy-assisted Gastrectomy |
Primary outcome
Operative time
Time frame: During procedure.
The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy.
8 secondary outcomes
Blood pressure
Time frame: Through study completion, an average of 2 year.
End-tidal carbon dioxide
Time frame: Through study completion, an average of 2 year.
Heart rate
Time frame: Through study completion, an average of 2 year.
Estimated blood loss
Time frame: Through study completion, an average of 2 year.
Complications
Time frame: Through study completion, an average of 2 year.
Death
Time frame: Through study completion, an average of 2 year.
Blood transfusion
Time frame: Through study completion, an average of 2 year.
Tumor size
Time frame: Through study completion, an average of 2 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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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.
Yingwei Xue, doctor study director
Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Laparoscopy and Gasless Laparoscopy in people with Gastrectomy and Laparoscopy, run by Xue Yingwei at 1 site in China.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. 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 China. 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?
Results are not available in the source record.
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?
Operative time (time frame: During procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.