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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jiajie Zhou
Coordinator of this site? Confirm its status
YangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.