Quality of LifeNCT04164095
A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus
A study testing lappg in people with Quality of Life, run by RenJi Hospital.
Trial summary
For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- lappg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old < age < 75 years old;
- primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;
- the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;
- it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;
- preoperative ECoG physical state score 0 / 1;
- preoperative ASA score I-III;
- informed consent of patients.
Who cannot join
- pregnant or lactating women; suffering from serious mental illness;
- the history of upper abdominal surgery (except laparoscopic cholecystectomy);
- history of gastric surgery (including ESD / EMR for gastric cancer);
- preoperative imaging examination showed regional enlarged lymph nodes;
- having other malignant diseases within 5 years;
- patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;
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- there was a history of unstable angina or myocardial infarction within 6 months;
- have a history of cerebral infarction or cerebral hemorrhage within 6 months;
- there was a history of continuous systemic corticosteroid therapy within 1 month;
- simultaneous surgical treatment of other diseases is needed;
- gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;
- FEV1 of pulmonary function examination was less than 50% of the predicted value.
About this study
Official title: A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus and Vagus Nerve on the Postoperative Quality of Life in Patients With Early Gastric Cancer
For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the influence of two surgical methods on the long-term quality of life of patients after operation
- Conditions
- Quality of Life
- Being tested
- lappg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lappgProcedure or surgery
Preservation of pylorus and vagus nerve by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| lappg | Experimental | Not described Receives: Procedure: lappg |
| ladgbi | Active comparator | Not described Receives: Procedure: lappg |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC-QLQ-C30
score: 0-100. more global and functional scales is better. less symptom scales is better
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, Affiliated Hospital of Qinghai University, Zhejiang Cancer Hospital, Second Affiliated Hospital of Suzhou University
- Responsible party
- Principal investigator, zhaogang, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164095
- Sponsor's protocol ID
- LVLM
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus and Vagus Nerve on the Postoperative Quality of Life in Patients With Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT04164095
- Acronym / sponsor ID
- LVLM
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, Affiliated Hospital of Qinghai University, Zhejiang Cancer Hospital, Second Affiliated Hospital of Suzhou University
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Nov 2019 (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.
For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the influence of two surgical methods on the long-term quality of life of patients after operation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lappg | Experimental | Procedure: lappg |
| ladgbi | Active comparator | Procedure: lappg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old < age < 75 years old;
- primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;
- the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;
- it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;
- preoperative ECoG physical state score 0 / 1;
Key exclusion criteria (12 listed)
- pregnant or lactating women; suffering from serious mental illness;
- the history of upper abdominal surgery (except laparoscopic cholecystectomy);
- history of gastric surgery (including ESD / EMR for gastric cancer);
- preoperative imaging examination showed regional enlarged lymph nodes;
- having other malignant diseases within 5 years;
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 |
|---|---|---|
| lappgPreservation of pylorus and vagus nerve by laparoscopy | Procedure or surgery | ladgbi, lappg |
Primary outcome
EORTC-QLQ-C30
Time frame: 5 years
score: 0-100. more global and functional scales is better. less symptom scales is better
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing lappg in people with Quality of Life, run by RenJi Hospital.
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 12 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 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
EORTC-QLQ-C30 (time frame: 5 years). 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 5 Dec 2019.