Clinical trial NCT06347757: A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-Reflux Alimentary Reconstruction
Laparoscopic Proximal Gastrectomy
Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.

Detailed description: In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-75 years old, male or female;
2. 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);
3. American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
4. 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;
5. Patients without contraindications to surgery;
6. Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;

Exclusion Criteria:

1. Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
2. Combined resection required due to other diseases (except cholecystectomy).
3. History of cancer or concurrent cancer in other organs.
4. Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
5. Patients with coagulation dysfunction which could not be corrected;
6. Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
7. Receipt of chemotherapy or radiotherapy before either surgical procedure.

Primary outcomes:
measure: Incidence of reflux esophagitis
timeFrame: At 1 year after LPG
Secondary outcomes:
measure: Incidence of anastomotic leakage
timeFrame: At 1 year after LPG
measure: Incidence of anastomotic stenosis
timeFrame: At 1 year after LPG
measure: Operative time
timeFrame: Intraoperative
measure: Intra-operative blood loss
timeFrame: Intraoperative
measure: Overall survival, and disease-free survival
timeFrame: At 1 and 3 years after LPG
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Jiajie Zhou
Study officials:
References: