Clinical trial NCT03874871: Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
Official title: Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Gastrostomy
Keywords: gastric cancer
function preserving gastrectomy
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
name: Peking Union Medical College Hospital
name: Beijing Friendship Hospital
name: Peking University Third Hospital
name: Chinese PLA General Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Beijing Hospital
name: Peking University People's Hospital
First posted: 2019-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-advanced gastric cancer patients with the clinical stage cT1-2 that are indicated for gastrectomy

Brief summary: The real world based multi-cohorts study aims to evaluate the safety and effectiveness of function preserving gastrectomy including pylorus-preserving distal gastrectomy, proximal gastrectomy and wedge gastrectomy for T1 and T2 gastric cancer patients.

Detailed description: Gastric cancer patients with clinical stage T1/2 will be screened for the study. For the patients enrolled, a multidisciplinary discussion will be performed to evaluate the proper gastrectomy for the patients and functional preserving gastrectomy will be considered for the indicated patients. For patients not proper for functional preserving gastrectomy, standard gastrectomies will be suggested. After surgery, a close follow up will be performed. During the study, a thorough data collection will be performed to evaluate the safety and effectiveness of functional preserving gastrectomy and recovery and postoperative function of remnant stomach.

Eligibility criteria: Inclusion Criteria:

* Karnofsky performance over 70%
* Histologically proven gastric or gastroesophageal joint adenocarcinoma with clinical stage T1-2N0-3M0
* No severe comorbidity with estimated survival less than 5 years

Exclusion Criteria:

* pregnancy
* Signs of distant metastases
* received chemotherapy, radiotherapy, immune therapy
* received gastrectomy
* other malignant tumors within 5 years except for cured skin cancer and cervical caner in situ.
* uncontrolled epilepsy, central nervus system disease or mental disease that affect the compliance of treatment and follow-up
* severe heart disease
* organ transplantation that needs immunosuppressor
* emergency surgery due to hemorrhage, perforation and ileus of gastric cancer

Primary outcomes:
measure: R0 resection rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Extent of lymphadenectomy of different gastrectomy
timeFrame: 30 days after surgery
measure: Distribution of metastatic lymph node
timeFrame: 30 days after surgery
measure: postoperative morbidity
timeFrame: 30 days after surgery
measure: postoperative mortality
timeFrame: 30 days after surgery
measure: remnant stomach function
timeFrame: 3 years after surgery
measure: disease free survival
timeFrame: 3 years after surgery
measure: Quality of life after surgery
timeFrame: 3 years after surgery
measure: overall survival
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ziyu Li, MD
role: STUDY_CHAIR
References: