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

NCT ID: NCT07080879

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Linear Anastomat Group (L Group)

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.

Group Type: EXPERIMENTAL

Linear Anastomat

Intervention Type: DEVICE

The product registration certificate numbers of linear anastomat is Su Wei registered 20202021581.

Tubular Anastomat Group (C Group)

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.

Group Type: ACTIVE_COMPARATOR

Tubular Anastomat

Intervention Type: DEVICE

The product registration certificate numbers of tubular anastomat is Su Wei registered 20182020305.

Interventions

Linear Anastomat

The product registration certificate numbers of linear anastomat is Su Wei registered 20202021581.

Intervention Type: DEVICE

Tubular Anastomat

The product registration certificate numbers of tubular anastomat is Su Wei registered 20182020305.

Intervention Type: DEVICE

Eligibility Criteria

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；

9. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital, Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

STAPLER01

Identifier Type: -

Identifier Source: org_study_id