Gastric CancerNCT05541783
Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
A study testing laparoscopy-assisted distal gastrectomy Group and Totally laparoscopic distal gastrectomy in people with Gastric Cancer, run by Fudan University at 2 sites in China.
Trial summary
The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- laparoscopy-assisted distal gastrectomy Group and Totally laparoscopic distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2022to 15 Jan 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-80 years;
- Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
- Patients had histologically confirmed gastric adenocarcinoma (tumor size<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition;
- Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.
Who cannot join
- Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
- Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
- Patients had any concurrent or previous malignant tumor;
- Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
- Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Changhai Hospital
Shanghai, Shanghai Municipality, 200000
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer
The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- laparoscopy-assisted distal gastrectomy Group, Totally laparoscopic distal gastrectomy
- Keywords
- Gastric cancer，Laparoscopic distal 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.
laparoscopy-assisted distal gastrectomy GroupProcedure or surgery
LADG
Totally laparoscopic distal gastrectomyProcedure or surgery
TLDG
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy-assisted distal gastrectomy | Active comparator | The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction. Receives: Procedure: laparoscopy-assisted distal gastrectomy Group |
| Totally laparoscopic distal gastrectomy | Experimental | The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy. Receives: Procedure: Totally laparoscopic distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively
Measured: 30 days postoperatively
Secondary outcomes (5)
Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively
Scores on the other scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively
Measured: 30 days postoperatively
Scores on EORTC QLQ-C30 questionnaire
Scores on EORTC QLQ-C30 questionnaire at 7 days and 90 days postoperatively
Measured: 7 days and 90 days postoperatively
Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively
Scores on the scales of EORTC QLQ-STO22 questionnaire at 7，30 and 90 days postoperatively
Measured: 7，30 and 90 days postoperatively
hospital stay cost
Measured: 30-day
Intraoperative and postoperative morbidities and mortality
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start15 Sep 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
- Investigators
- Dazhi Xu, PHD, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541783
- Sponsor's protocol ID
- LATDG
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer
- ClinicalTrials.gov ID
- NCT05541783
- Acronym / sponsor ID
- LATDG
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer，Laparoscopic distal gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 15 Sep 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 study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy-assisted distal gastrectomy | Active comparator | Procedure: laparoscopy-assisted distal gastrectomy GroupThe patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction. |
| Totally laparoscopic distal gastrectomy | Experimental | Procedure: Totally laparoscopic distal gastrectomyThe patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20-80 years;
- Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
- Patients had histologically confirmed gastric adenocarcinoma (tumor size<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition;
- Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.
Key exclusion criteria (5 listed)
- Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
- Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
- Patients had any concurrent or previous malignant tumor;
- Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
- Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).
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 |
|---|---|---|
| laparoscopy-assisted distal gastrectomy GroupLADG | Procedure or surgery | Laparoscopy-assisted distal gastrectomy |
| Totally laparoscopic distal gastrectomyTLDG | Procedure or surgery | Totally laparoscopic distal gastrectomy |
Primary outcome
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire
Time frame: 30 days postoperatively
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively
5 secondary outcomes
Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively
Time frame: 30 days postoperatively
Scores on EORTC QLQ-C30 questionnaire
Time frame: 7 days and 90 days postoperatively
Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively
Time frame: 7，30 and 90 days postoperatively
hospital stay cost
Time frame: 30-day
Intraoperative and postoperative morbidities and mortality
Time frame: 90-day
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 30 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Dazhi Xu, PHD, MD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy-assisted distal gastrectomy Group and Totally laparoscopic distal gastrectomy in people with Gastric Cancer, run by Fudan University at 2 sites 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 4 inclusion and 5 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire (time frame: 30 days postoperatively). 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 30 Jun 2026.