Early Gastric CancerLAPPGNCT02936193
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer
A study testing Pylorus preservation and Distal gastrectomy in people with Early Gastric Cancer, run by RenJi Hospital at 2 sites in China.
Trial summary
The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Pylorus preservation and Distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2017to Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age older than 18 and younger than 75 years
- Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition
- Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy
- Written informed consent
Who cannot join
- Pregnant or breast-feeding women
- Severe mental disorder
- Previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
- Other malignant disease within the past 5 years
- Previous neoadjuvant chemotherapy or radiotherapy
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- Unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months
- Continuous systematic administration of corticosteroids within 1 month before the study
- Requirement of simultaneous surgery for other diseases
- Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Qi Lu, 0086-021-68383364, rjluqi@hotmail.com
- Recruiting
Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Hui Cao, PhD, 0086-021-686383751, caohuishcn@hotmail.com
About this study
Official title: Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial
The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.
Read the detailed description
During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured
- Conditions
- Early Gastric Cancer
- Being tested
- Pylorus preservation, 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.
Pylorus preservationProcedure or surgery
Also called Laparoscopic-assisted pylorus preserving gastrectomy
Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation
Distal gastrectomyProcedure or surgery
Also called Laparoscopic-assisted distal gastrectomy
Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Pylorus preservation | Experimental | Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation Receives: Procedure: Pylorus preservation |
| Distal gastrectomy | Active comparator | Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy Receives: Procedure: Distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
It is the time that passes from the first date after treatment and the date on which gastric cancer progresses, as demonstrated by laboratory testing, radiologic testing, or clinically.
Measured: 3 years
Secondary outcomes (3)
Postoperative complications
Measured: 30 days
Postoperative mortality
Measured: 30 days
3 years overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start1 Aug 2017
- Primary completion2 Nov 2019
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936193
- Sponsor's protocol ID
- LAPPG
- Acronym
- LAPPG
- Status last verified
- Apr 2019
- First submitted
- 7 Oct 2016
- Last updated
- 5 Nov 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 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02936193
- Acronym / sponsor ID
- LAPPG / LAPPG
- Conditions
- Early Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 2 Nov 2019 (actual)
- Study completion
- Oct 2020 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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 safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.
Detailed description
During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pylorus preservation | Experimental | Procedure: Pylorus preservationPatients undergo Laparoscopic Gastrectomy with Pylorus-preservation |
| Distal gastrectomy | Active comparator | Procedure: Distal gastrectomyPatients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age older than 18 and younger than 75 years
- Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition
- Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy
- Written informed consent
Key exclusion criteria (10 listed)
- Pregnant or breast-feeding women
- Severe mental disorder
- Previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
- Other malignant disease within the past 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 |
|---|---|---|
| Pylorus preservationAlso: Laparoscopic-assisted pylorus preserving gastrectomyPatients undergo Laparoscopic Gastrectomy featuring pylorus-preservation | Procedure or surgery | Pylorus preservation |
| Distal gastrectomyAlso: Laparoscopic-assisted distal gastrectomyPatients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy | Procedure or surgery | Distal gastrectomy |
Primary outcome
Progression-free Survival
Time frame: 3 years
It is the time that passes from the first date after treatment and the date on which gastric cancer progresses, as demonstrated by laboratory testing, radiologic testing, or clinically.
3 secondary outcomes
Postoperative complications
Time frame: 30 days
Postoperative mortality
Time frame: 30 days
3 years overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pylorus preservation and Distal gastrectomy in people with Early Gastric Cancer, run by RenJi Hospital 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 5 inclusion and 10 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 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Tu, MD (008618616547270, tl19870228@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 3 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 Nov 2019.