NCT06347757Completed
A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy
A 3-Arm Study Comparing the Efficacy of Anti-Reflux Alimentary Reconstruction Protocols (Single-Tract Jejunal Interposition vs Double Tract vs Tube-Like Stomach Reconstruction) After Laparoscopic Proximal Gastrectomy
Source: ClinicalTrials.gov · Last updated 30 Apr 2024
Brief summary (registry, in English)
The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 29 Mar 2024
- Start date
- 1 Jan 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Northern Jiangsu People's Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06347757
What you commit to
- Study type: Interventional
- Participants enrolled: 180
- From 1 Jan 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
- Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
- Receipt of chemotherapy or radiotherapy before either surgical procedure.
Other illness
- Combined resection required due to other diseases (except cholecystectomy).
- History of cancer or concurrent cancer in other organs.
Other
- Patients with coagulation dysfunction which could not be corrected;
- Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
Who the study is looking for
- Age between 18-75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
- American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
- Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC;
- Patients without contraindications to surgery;
- Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiajie Zhou Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.