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NCT Number: NCT07080879

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Unable or unwilling to comply with research requirements;
  • Patients with PD after neoadjuvant chemotherapy and unable to undergo distal gastrectomy;
  • Patients undergoing emergency surgery due to tumor bleeding, perforation and obstruction during chemotherapy.

Treatment and study plan

Linear Anastomat

Device

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

Tubular Anastomat

Device

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

Primary outcomes

  1. Incidence of Intraoperative Splenic Laceration

    Time frame: Perioperative period

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

  2. Incidence of Positive Incisal Margin

    Time frame: Perioperative period

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

  3. Incidence of Anastomosis Failure

    Time frame: Perioperative period

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

Secondary outcomes

  1. Change in Procalcitonin Levels

    Time frame: Perioperative period

    The mean and standard deviation of procalcitonin (pg/mL or ng/mL) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).

  2. Change in C-Reactive Protein Levels

    Time frame: Perioperative period

    The mean and standard deviation of C-reactive protein (mg/L) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).

  3. Change in TNF-α Levels

    Time frame: Perioperative period

    The mean and standard deviation of TNF-α (pg/mL) measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).

  4. Change in Interleukin-6 Levels

    Time frame: Perioperative period

    The mean and standard deviation of the percentage of CD3+, CD4+, CD8+, and NK cells among total lymphocytes, measured at designated time points (e.g., pre-operation, 1st post-operative day, 3rd post-operative day).

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

    Time frame: 3 years

    The mean and standard deviation of the overall global health status/quality of life score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), ranging from 0 to 100, with higher scores indicating better quality of life.

  6. Disease-Specific Quality of Life assessed by EORTC QLQ-STO22 Score

    Time frame: 3 years

    The mean and standard deviation of relevant symptom scales and functional scales from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach Module (EORTC QLQ-STO22).

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

Clinical Study on the Advantages and Disadvantages of Linear Anastomat and Tubular Anastomat in Gastrointestinal Anastomosis During Radical Gastrectomy for Distal Gastric Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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