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

NCT ID: NCT05539105

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2029-12-31

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.

Conditions

Proximal Gastric Adenocarcinoma; Reconstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Double tract reconstruction

Double tract reconstruction would be applied after proximal gastrectomy

Double tract reconstruction

Intervention Type: PROCEDURE

Double tract reconstruction would be applied after radical proximal gastrectomy.

Gastric conduit reconstruction

Gastric conduit reconstruction would be applied after proximal gastrectomy

Gastric conduit reconstruction

Intervention Type: PROCEDURE

Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.

Other reconstructions

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy

Other reconstructions

Intervention Type: PROCEDURE

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Interventions

Double tract reconstruction

Double tract reconstruction would be applied after radical proximal gastrectomy.

Intervention Type: PROCEDURE

Gastric conduit reconstruction

Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.

Intervention Type: PROCEDURE

Other reconstructions

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Intervention Type: 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ping Shu, PHD

Role: primary

shu.ping@zs-hospital.sh.cn

021-64041990

Other Identifiers

STAR-PG01

Identifier Type: -

Identifier Source: org_study_id