A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy (STAR-PG01)
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital Fudan University
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Contact:
- Ping Shu, PHD
- Phone Number: 021-64041990
- Email: shu.ping@zs-hospital.sh.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Double tract reconstruction
Double tract reconstruction would be applied after proximal gastrectomy
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Double tract reconstruction would be applied after radical proximal gastrectomy.
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Gastric conduit reconstruction
Gastric conduit reconstruction would be applied after proximal gastrectomy
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Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.
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Other reconstructions
Other reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy
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Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reflux esophagitis incidence 1 year after surgery
Time Frame: 1 year
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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.
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morbidity after surgery
Time Frame: 30 days
|
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;
|
30 days
|
|
Body weight(kg) after surgery
Time Frame: 12 months
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Body weight(kg)would be monitored during follow-up after surgery.
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12 months
|
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Albumin(g/L) after surgery
Time Frame: 12 months
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Albumin(g/L) would be monitored during follow-up after surgery.
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12 months
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Hemoglobin(g/L) after surgery
Time Frame: 12 months
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Hemoglobin(g/L) would be monitored during follow-up after surgery.
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12 months
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3-year relapse free survival rate
Time Frame: 3 years
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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. |
3 years
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Mortality after surgery
Time Frame: 30 days
|
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:
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAR-PG01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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