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A prospective multicenter clinical study evaluating the safety and efficacy of SIS Staple Line Reinforcement for gastrointestinal reconstruction in radical resection of esophageal gastric junction adenocarcinoma

A prospective multicenter clinical study evaluating the safety and efficacy of SIS Staple Line Reinforcement for gastrointestinal reconstruction in radical resection of esophageal gastric junction adenocarcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085049
Enrollment
Unknown
Registered
2024-05-30
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagogastric junction adenocarcinoma

Interventions

Research Group :The reconstruction of the digestive tract requires the use of instruments for anastomosis and barbed wire to close the joint opening of the esophagus, stomach, or esophagus and jejunum

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Informed consent of patients and their families 2) 18 years old < age < 80 years old 3) Preoperative gastroscopic pathological biopsy showed histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, sig-ring cell carcinoma, poorly differentiated adenocarcinoma, mixed type adenocarcinoma); 4) After gastroscopy, abdominal CT or upper gastrointestinal angiography, the tumor location was consistent with the definition of Siewert type II esophagogastric junction adenocarcinoma in the "Chinese expert Consensus", that is, the tumor center was within the interval of 1cm above and 2cm below the anatomical junction of esophagus and stomach, and crossed or touched the esophagogastric junction. 5) Abdominal enhanced CT/MRI with clinical staging of cT1b-4aN0-3M0 (according to AJCC-8thTNM tumor staging); 6) Karnofsky physical condition score =70%; Or ECOG score =2 points; 7) Preoperative ASA score I-III

Exclusion criteria

Exclusion criteria: 1) Middle and upper mediastinal lymph node metastasis was clinically diagnosed; 2) Pregnant or nursing women; 3) Have a history of uncontrolled seizures, central nervous system diseases or mental disorders; 4) Clinically serious heart disease, such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the last 6 months. Or have a history of cerebral infarction or cerebral hemorrhage within the last 6 months; 5) Moderate or severe renal injury [creatinine clearance rate equal to or less than 50ml/min (calculated according to Cockroft and Gault equations)], or serum creatinine>upper normal limit (ULN); 6) Emergency surgery due to tumor emergencies (bleeding, perforation, obstruction); 7) Patients who are unable to perform instrument matching;

Design outcomes

Primary

MeasureTime frame
The incidence of anastomotic complications.;

Secondary

MeasureTime frame
30-day postoperative complication rates;surgical time ;Early postoperative recovery process;Incidence of anastomotic leakage ;

Countries

China

Contacts

Public ContactWei Wang

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

wangwei16400@163.com+86 139 2225 5515

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026