Proximal Gastric AdenocarcinomaSTAR-PG01NCT05539105
A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
An observational study of Proximal Gastric Adenocarcinoma and Reconstruction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Proximal Gastric Adenocarcinoma, Reconstruction
- What is being tested?
- Double tract reconstruction, Gastric conduit reconstruction and Other reconstructions
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2022to 31 Dec 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Adult, Older adult
Study population: This study is a prospective, multi-center, open, observational, real-world registry study, prospectively and consecutively enrolling patients undergoing proximal gastric surgery in several important gastric cancer across the country. This study emphasizes the continuity of enrolled patients and the breadth of data sources to reflect the real clinical situation. This study plans to include about 10 centers across the country, and plans to enroll consecutive patients who will undergo radical proximal gastrectomy within 2 years. It is expected that a total of 600 prospective registry cases will be included.
Who may be able to join
- Aged 18-80 years
- Tumor located in the upper or esophagogastric junction (EGJ), and curative resection with more than 1/2 remant is expected to be achievable by proximal gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
- Clinical stage T1NxM0 (According to AJCC-8th TNM staging system) of the upper stomach or diameter of EGJ cancer less than 4cm with invading esophgus no more than 2cm without any distant metastasis;
- Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
- Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
- Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
- Sufficient organ functions
- Written informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Ping Shu, PHD, 021-64041990, shu.ping@zs-hospital.sh.cn
About this study
This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy.
Read the detailed description
- The patient was admitted to the hospital, and at the time of physical examination, the following conditions were met: 18 years old ≤ age ≤ 80 years old; preoperative ECOG performance status score 0/1; non-pregnant or lactating women; no serious mental illness; no serious respiratory disease; No severe hepatic and renal insufficiency; no history of unstable angina pectoris and myocardial infarction within 6 months; no history of cerebral infarction or cerebral hemorrhage within 6 months, except for old cavity infarction; no history of continuous glucocorticoid therapy (local Except for applications); pulmonary function test showed FEV1 ≥ 50% of the predicted value. The patient did not participate in other clinical studies (within 6 months).
- gastric adenocarcinoma was diagnosed by endoscopic examination and histopathological biopsy of the patient's primary lesion, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly adherent carcinoma (including signet ring cell carcinoma and other types), Mixed adenocarcinoma, etc. In qualified units, endoscopic ultrasonography (EUS) is recommended. The tumor is located in the upper part of the stomach or at the esophagogastric junction (tumor diameter is less than 4cm, and the length of invasion of the esophagus is less than 2cm);
- Enhanced CT scan of the abdomen and pelvis was performed on the patient. For upper gastric cancer, no tumor invading the muscular layer, subserosal layer or serosa layer was found, and no distant metastasis occurred; for esophagogastric junction cancer, no distant metastasis occurred;
- The patient has a clear diagnosis of gastric adenocarcinoma, and it is expected that proximal gastrectomy and lymph node dissection can be performed to obtain an R0 surgical result. .
- The patient's ASA is I-III. ⑥ At this point, the patient becomes a potential selected case and enters the case selection procedure.
- Conditions
- Proximal Gastric Adenocarcinoma, Reconstruction
- Being tested
- Double tract reconstruction, Gastric conduit reconstruction, Other reconstructions
- Keywords
- Proximal gastrectomy, Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double tract reconstructionProcedure or surgery
Double tract reconstruction would be applied after radical proximal gastrectomy.
Gastric conduit reconstructionProcedure or surgery
Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.
Other reconstructionsProcedure or surgery
Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Double tract reconstruction | Double tract reconstruction would be applied after proximal gastrectomy Receives: Procedure: Double tract reconstruction | |
| Gastric conduit reconstruction | Gastric conduit reconstruction would be applied after proximal gastrectomy Receives: Procedure: Gastric conduit reconstruction | |
| Other reconstructions | Other reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy Receives: Procedure: Other reconstructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux esophagitis incidence 1 year after surgery
Reflux esophagitis refers to esophageal erosions and/or esophageal ulcers caused by the reflux of esophageal contents into the esophagus or above (oral mouth, throat, lungs) causing complaints of discomfort and endoscopic manifestations of esophageal mucosal defects.
Measured: 1 year
Secondary outcomes (6)
Morbidity after surgery
Take the total number of patients receiving surgical treatment as the denominator, and the number of patients with intraoperative/postoperative early and late complications during any one and follow-up as the numerator to calculate the proportion;
Measured: 30 days
Body weight(kg) after surgery
Body weight(kg)would be monitored during follow-up after surgery.
Measured: 12 months
Albumin(g/L) after surgery
Albumin(g/L) would be monitored during follow-up after surgery.
Measured: 12 months
Hemoglobin(g/L) after surgery
Hemoglobin(g/L) would be monitored during follow-up after surgery.
Measured: 12 months
3-year relapse free survival rate
The time between the date of surgery as the starting point and the date of tumor recurrence as the ending point (or the date of death due to tumor cause when the exact date of tumor recurrence is not known).
When neither death nor tumor recurrence was observed at follow-up, the final date of confirmation of recurrence-free survival (final recurrence-free survival confirmation date: the last of the date of the outpatient visit or the date of the examination received) was used.
Measured: 3 years
Mortality after surgery
Taking the total number of patients receiving surgical treatment as the denominator, and observing any of the following patients as the numerator, the ratio calculated as the surgical death ratio:
- According to the observation items during the operation and the observation items after the operation, it will be recorded as death;
- All patients who died from the start of the operation to within 30 days after the operation (including 30 days) (regardless of whether the cause of death was causally related to the operation);
- In a longer period of time after 31 days after the operation, there is definite evidence that the death of the patient has a direct causal relationship with the first operation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start22 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539105
- Sponsor's protocol ID
- STAR-PG01
- Acronym
- STAR-PG01
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 14 Sep 2022
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
- ClinicalTrials.gov ID
- NCT05539105
- Acronym / sponsor ID
- STAR-PG01 / STAR-PG01
- Conditions
- Proximal Gastric Adenocarcinoma, Reconstruction
- Keywords
- Proximal gastrectomy, Reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 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.
This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy.
Detailed description
- The patient was admitted to the hospital, and at the time of physical examination, the following conditions were met: 18 years old ≤ age ≤ 80 years old; preoperative ECOG performance status score 0/1; non-pregnant or lactating women; no serious mental illness; no serious respiratory disease; No severe hepatic and renal insufficiency; no history of unstable angina pectoris and myocardial infarction within 6 months; no history of cerebral infarction or cerebral hemorrhage within 6 months, except for old cavity infarction; no history of continuous glucocorticoid therapy (local Except for applications); pulmonary function test showed FEV1 ≥ 50% of the predicted value. The patient did not participate in other clinical studies (within 6 months).
- gastric adenocarcinoma was diagnosed by endoscopic examination and histopathological biopsy of the patient's primary lesion, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly adherent carcinoma (including signet ring cell carcinoma and other types), Mixed adenocarcinoma, etc. In qualified units, endoscopic ultrasonography (EUS) is recommended. The tumor is located in the upper part of the stomach or at the esophagogastric junction (tumor diameter is less than 4cm, and the length of invasion of the esophagus is less than 2cm);
- Enhanced CT scan of the abdomen and pelvis was performed on the patient. For upper gastric cancer, no tumor invading the muscular layer, subserosal layer or serosa layer was found, and no distant metastasis occurred; for esophagogastric junction cancer, no distant metastasis occurred;
- The patient has a clear diagnosis of gastric adenocarcinoma, and it is expected that proximal gastrectomy and lymph node dissection can be performed to obtain an R0 surgical result. .
- The patient's ASA is I-III. ⑥ At this point, the patient becomes a potential selected case and enters the case selection procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double tract reconstruction | – | Procedure: Double tract reconstructionDouble tract reconstruction would be applied after proximal gastrectomy |
| Gastric conduit reconstruction | – | Procedure: Gastric conduit reconstructionGastric conduit reconstruction would be applied after proximal gastrectomy |
| Other reconstructions | – | Procedure: Other reconstructionsOther reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective, multi-center, open, observational, real-world registry study, prospectively and consecutively enrolling patients undergoing proximal gastric surgery in several important gastric cancer across the country. This study emphasizes the continuity of enrolled patients and the breadth of data sources to reflect the real clinical situation. This study plans to include about 10 centers across the country, and plans to enroll consecutive patients who will undergo radical proximal gastrectomy within 2 years. It is expected that a total of 600 prospective registry cases will be included.
Key inclusion criteria (8 listed)
- Aged 18-80 years
- Tumor located in the upper or esophagogastric junction (EGJ), and curative resection with more than 1/2 remant is expected to be achievable by proximal gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
- Clinical stage T1NxM0 (According to AJCC-8th TNM staging system) of the upper stomach or diameter of EGJ cancer less than 4cm with invading esophgus no more than 2cm without any distant metastasis;
- Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
- Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Double tract reconstructionDouble tract reconstruction would be applied after radical proximal gastrectomy. | Procedure or surgery | Double tract reconstruction |
| Gastric conduit reconstructionGastric conduit reconstructionn would be applied after radical proximal gastrectomy. | Procedure or surgery | Gastric conduit reconstruction |
| Other reconstructionsOther reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy. | Procedure or surgery | Other reconstructions |
Primary outcome
Reflux esophagitis incidence 1 year after surgery
Time frame: 1 year
Reflux esophagitis refers to esophageal erosions and/or esophageal ulcers caused by the reflux of esophageal contents into the esophagus or above (oral mouth, throat, lungs) causing complaints of discomfort and endoscopic manifestations of esophageal mucosal defects.
6 secondary outcomes
Morbidity after surgery
Time frame: 30 days
Body weight(kg) after surgery
Time frame: 12 months
Albumin(g/L) after surgery
Time frame: 12 months
Hemoglobin(g/L) after surgery
Time frame: 12 months
3-year relapse free survival rate
Time frame: 3 years
Mortality after surgery
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Gastric Adenocarcinoma and Reconstruction, run by Shanghai Zhongshan Hospital 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 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: looking for participants now, as of the sponsor's last update on 14 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux esophagitis incidence 1 year after surgery (time frame: 1 year). 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 14 Sep 2022.