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

NCT07080879 | Active Not Recruiting

• 1 other identifier: STAPLER01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

Linear Anastomat and Tubular Anastomat; Distal radical gastrectomy; Gastroenterostomy

Outcome Measures

Primary Outcomes (3)

• Incidence of Intraoperative Splenic Laceration

  The number and percentage of participants experiencing splenic laceration during surgery.

  Perioperative period

• Incidence of Positive Incisal Margin

  The number and percentage of participants with a positive incisal margin after tumor resection.

  Perioperative period

• Incidence of Anastomosis Failure

  The number and percentage of participants experiencing anastomosis failure during surgery.

  Perioperative period

Secondary Outcomes (6)

• Change in Procalcitonin Levels

  Perioperative period

• Change in C-Reactive Protein Levels

  Perioperative period

• Change in TNF-α Levels

  Perioperative period

• Change in Interleukin-6 Levels

  Perioperative period

• Health-Related Quality of Life assessed by EORTC QLQ-C30 Overall Score

  3 years

Study Arms (2)

Linear Anastomat Group (L Group)

EXPERIMENTAL

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.

Device: Linear Anastomat

Tubular Anastomat Group (C Group)

ACTIVE COMPARATOR

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.

Device: Tubular Anastomat

Interventions

Linear Anastomat DEVICE

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

Linear Anastomat Group (L Group)

Tubular Anastomat DEVICE

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

Tubular Anastomat Group (C Group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≤ 18 years old ≤75 years old;
• 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.
• The patient was clinically diagnosed with gastric cancer (in line with clinical signs of gastrointestinal reconstruction after distal subtotal gastrectomy for gastric cancer);
• Implantation metastasis without peritoneum (confirmed by laparoscopic exploratory surgery);
• It is estimated that R0 results can be obtained after D2 radical resection of distal gastric cancer (also applicable for multiple primary lower cancers);
• Karnofsky score ≥60 points;
• 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；
• \. Blood biochemical examination: BIL \<1.5 times the upper limit of normal value (ULN);ALT and AST\<2.5× ULN;Crea≤1 x ULN.

You may not qualify if:

• Previous history of upper abdominal surgery (including gastric ESD/EMR, except laparoscopic cholecystectomy);
• History of acute pancreatitis;
• Preoperative imaging examination indicated fusion of enlarged lymph nodes (maximum diameter \>3cm);
• Gastric cancer patients who have received neoadjuvant therapy;
• History of other malignant diseases within the past 5 years;
• History of unstable angina pectoris, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
• History of continuous systemic corticosteroid therapy in the past 1 month;
• Concurrent surgical treatment for other diseases is required;
• Patients with gastric cancer complications (bleeding, perforation) requiring emergency surgery;
• Pyloric obstruction;
• Lung function test FEV1\< 50% of the expected value;
• Pregnant or lactating women;
• Suffers from severe mental illness;
• Participate in other clinical studies at the same time;
• Refused to sign the first round of study informed consent;

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: July 23, 2025
• Study Start: June 1, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-03

Locations

CN (1)