A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy (STAR-PG01)

Fudan University

Status

Enrolling

Conditions

Reconstruction

Proximal Gastric Adenocarcinoma

Treatments

Procedure: Double tract reconstruction

Procedure: Other reconstructions

Procedure: Gastric conduit reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT05539105

STAR-PG01

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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