The Advantages and Disadvantages of Linear Anastomat and Tubular Anastomat in Radical Gastrectomy of Distal Gastric Cancer

Central South University

Status: Active, not recruiting

Conditions: Gastric Cancer

Treatments: Device: Tubular Anastomat; Device: Linear Anastomat

Study type: Interventional

Funder types: Other

Identifiers

NCT07080879

STAPLER01

Details and patient eligibility

About

The goal of this clinical trial is to observe and compare the short-term complications, long-term survival and quality of life of linear anastomat and tubular anastomat during digestive tract reconstruction after resection of distal gastric cancer.

Participants will receive a linear anastomat or tubular anastomat for digestive tract reconstruction during distal gastrectomy gastroenterostomy.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≤ 18 years old ≤75 years old;

2. The primary gastric lesions were diagnosed as gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, sig-ring cell carcinoma, and poorly differentiated adenocarcinoma por) by gastroscopic biopsy.

3. The patient was clinically diagnosed with gastric cancer (in line with clinical signs of gastrointestinal reconstruction after distal subtotal gastrectomy for gastric cancer);

4. Implantation metastasis without peritoneum (confirmed by laparoscopic exploratory surgery);

5. It is estimated that R0 results can be obtained after D2 radical resection of distal gastric cancer (also applicable for multiple primary lower cancers);

6. Karnofsky score ≥60 points;

7. Preoperative ASA score: I, II, or III; 8。 Routine blood examination (no transfusion within the past 14 days) : HB≥90g/L;ANC ≥1.5×109/L;PLT ≥80×109/L；

8. Blood biochemical examination: BIL <1.5 times the upper limit of normal value (ULN);ALT and AST<2.5× ULN;Crea≤1 x ULN.

Exclusion criteria

1. Previous history of upper abdominal surgery (including gastric ESD/EMR, except laparoscopic cholecystectomy);
2. History of acute pancreatitis;
3. Preoperative imaging examination indicated fusion of enlarged lymph nodes (maximum diameter >3cm);
4. Gastric cancer patients who have received neoadjuvant therapy;
5. History of other malignant diseases within the past 5 years;
6. History of unstable angina pectoris, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
7. History of continuous systemic corticosteroid therapy in the past 1 month;
8. Concurrent surgical treatment for other diseases is required;
9. Patients with gastric cancer complications (bleeding, perforation) requiring emergency surgery;
10. Pyloric obstruction;
11. Lung function test FEV1< 50% of the expected value;
12. Pregnant or lactating women;
13. Suffers from severe mental illness;
14. Participate in other clinical studies at the same time;
15. Refused to sign the first round of study informed consent;
16. Unable or unwilling to comply with research requirements;
17. Patients with PD after neoadjuvant chemotherapy and unable to undergo distal gastrectomy;
18. Patients undergoing emergency surgery due to tumor bleeding, perforation and obstruction during chemotherapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Linear Anastomat Group (L Group)

Experimental group

Description:

The duodenum and distal stomach were separated by linear anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the linear anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the linear anastomat.

Treatment:

Device: Linear Anastomat

Tubular Anastomat Group (C Group)

Active Comparator group

Description:

The duodenum and distal stomach were separated by tubular anastomat at the planned tangents, and the specimens were taken out to confirm the safe cutting edge.The two arms of the tubular anastomat were extended into the posterior wall of the duodenum and small openings at the stump of the greater curvature of the stomach respectively for cutting closure, and then the common openings were closed with the tubular anastomat.

Treatment:

Device: Tubular Anastomat