Trials / Completed
CompletedNCT06347757
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Northern Jiangsu People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Anti-Reflux Alimentary Reconstruction
- Laparoscopic Proximal Gastrectomy
- Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy | laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR). |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2023-12-31
- Completion
- 2024-03-15
- First posted
- 2024-04-04
- Last updated
- 2024-04-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06347757. Inclusion in this directory is not an endorsement.