NCT05539105

A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Proximal Gastric Adenocarcinoma
• Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Double tract reconstruction	Double tract reconstruction would be applied after radical proximal gastrectomy.
PROCEDURE	Gastric conduit reconstruction	Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.
PROCEDURE	Other reconstructions	Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Timeline

• Start date: 2022-08-22
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2022-09-14
• Last updated: 2022-09-14

Locations

1 site across 1 country: China