Gastric CancerPhase 3PRAPTNCT01433861
Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy
A Phase 3 study testing Laparoscopy-assisted gastrectomy in people with Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now. 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 gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Nov 2012
- Phase
- Phase 3
- 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
- Age 20~80
- Informed consent
- No other malignancies
- Proximal gastric cancer met by following conditions
- Lesion located on proximal stomach (upper one third)
- Lesion below 5cm in size
- Lesion confined to proper muscle depth (cT2)
- No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1)
Who cannot join
- If patients is only suitable to total gastrectomy, he will be excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Gyenggi
About this study
Official title: Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)
The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.
The primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we
Read the detailed description
Prospective Randomized Clinical Trials between Laparoscopy-assisted Proximal Gastrectomy and Laparoscopy-assisted Total Gastrectomy.
LAPG reconstruction: double tract reconstruction (3 anastomosis, intracorporeal Roux-en Y esophago-jejunostomy, extracorporeal gastro-jejunostomy 10cm below esophago-jejunostomy,extracorporeal jejuno-jejunostomy 20cm below gastro-jejunostomy)
LATG reconstruction: intracorporeal Roux-en Y esophago-jejunostomy
Primary end point : incidence of reflux esophagitis after operation
Sample Size : LAPG 97 cases, LATG 97 cases (p1=0.018 p2=0.018, a=0.05, b=0.80) Non-inferiority test, non-inferior margin (delta) : 0.05. Sample size calculated by our MRCC(Medical Research Collaborating Center, http://mrcc.snubh.org)
Study duration : 48 months (enrollment 36months, follow-up 12months)
Reflux esophagitis evaluation methods
- Ambulatory 24hr-pH esophageal holter monitoring for acid reflux
- DISIDA scan for bile reflux
- Endoscopic evaluation (Grading according to LA classification)
- Visick score (subjective symptoms)
- EORTC sto 22 and GIQLI evaluation (Quality of Life)
- Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test)
- Upper gastrointestinal study
- Gastric emptying scan
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopy-assisted gastrectomy
- Keywords
- gastric cancer, proximal gastrectomy, total gastrectomy, laparoscopy, reflux esophagitis, double tract reconstruction
- Medical subject headings
- Stomach Neoplasms, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy-assisted gastrectomyProcedure or surgery
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| LAPG | Active comparator | LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group Receives: Procedure: Laparoscopy-assisted gastrectomy |
| LATG | Active comparator | LATG : laparoscopy-assisted total gastrectomy group Receives: Procedure: Laparoscopy-assisted gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reflux esophagitis
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Measured: postoperative 3 month
Rate of reflux esophagitis
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Measured: postoperative 6 month
Rate of reflux esophagitis
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Measured: postoperative 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: We planed to study later
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Ho Kim, Seoul National University Bundang Hospital
- Investigators
- Hyung-Ho Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433861
- Sponsor's protocol ID
- SNUBHGS
- Acronym
- PRAPT
- Status last verified
- Jan 2017
- First submitted
- 10 Sep 2011
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)
- ClinicalTrials.gov ID
- NCT01433861
- Acronym / sponsor ID
- PRAPT / SNUBHGS
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, proximal gastrectomy, total gastrectomy, laparoscopy, reflux esophagitis, double tract reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We planed to study later
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Sep 2011 (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 choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.
The primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we
Detailed description
Prospective Randomized Clinical Trials between Laparoscopy-assisted Proximal Gastrectomy and Laparoscopy-assisted Total Gastrectomy.
LAPG reconstruction: double tract reconstruction (3 anastomosis, intracorporeal Roux-en Y esophago-jejunostomy, extracorporeal gastro-jejunostomy 10cm below esophago-jejunostomy,extracorporeal jejuno-jejunostomy 20cm below gastro-jejunostomy)
LATG reconstruction: intracorporeal Roux-en Y esophago-jejunostomy
Primary end point : incidence of reflux esophagitis after operation
Sample Size : LAPG 97 cases, LATG 97 cases (p1=0.018 p2=0.018, a=0.05, b=0.80) Non-inferiority test, non-inferior margin (delta) : 0.05. Sample size calculated by our MRCC(Medical Research Collaborating Center, http://mrcc.snubh.org)
Study duration : 48 months (enrollment 36months, follow-up 12months)
Reflux esophagitis evaluation methods
- Ambulatory 24hr-pH esophageal holter monitoring for acid reflux
- DISIDA scan for bile reflux
- Endoscopic evaluation (Grading according to LA classification)
- Visick score (subjective symptoms)
- EORTC sto 22 and GIQLI evaluation (Quality of Life)
- Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test)
- Upper gastrointestinal study
- Gastric emptying scan
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAPG | Active comparator | Procedure: Laparoscopy-assisted gastrectomyLAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group |
| LATG | Active comparator | Procedure: Laparoscopy-assisted gastrectomyLATG : laparoscopy-assisted total gastrectomy group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 20~80
- Informed consent
- No other malignancies
- Proximal gastric cancer met by following conditions
Key exclusion criteria (1 listed)
- If patients is only suitable to total gastrectomy, he will be excluded.
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 gastrectomyLaparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy | Procedure or surgery | LAPG, LATG |
Primary outcome
Rate of reflux esophagitis
Time frame: postoperative 3 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Rate of reflux esophagitis
Time frame: postoperative 6 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Rate of reflux esophagitis
Time frame: postoperative 12 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Results and safety
The study was stopped early (reason given: We planed to study later). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- 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.
Hyung-Ho Kim, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopy-assisted gastrectomy in people with Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 8 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Jan 2017. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We planed to study later). 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?
Rate of reflux esophagitis (time frame: postoperative 3 month). The study lists 3 primary outcomes in all. 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 9 Jan 2017.