Clinical trial NCT05539105: A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
Official title: A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Proximal Gastric Adenocarcinoma
Reconstruction
Keywords: Proximal gastrectomy
Reconstruction
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Reflux esophagitis incidence 1 year after surgery
timeFrame: 1 year
Secondary outcomes:
measure: Morbidity after surgery
timeFrame: 30 days
measure: Body weight(kg) after surgery
timeFrame: 12 months
measure: Albumin(g/L) after surgery
timeFrame: 12 months
measure: Hemoglobin(g/L) after surgery
timeFrame: 12 months
measure: 3-year relapse free survival rate
timeFrame: 3 years
measure: Mortality after surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
References: