An interventional study of Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy in Anti-Reflux Alimentary Reconstruction, Laparoscopic Proximal Gastrectomy and Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Northern Jiangsu People's Hospital · Not applicable, Interventional, and Treatment
The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 180 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy
Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy
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).
Incidence of reflux esophagitis
Time frame: At 1 year after LPG
Incidence of anastomotic leakage
Time frame: At 1 year after LPG
Incidence of anastomotic stenosis
Time frame: At 1 year after LPG
Operative time
Time frame: Intraoperative
Intra-operative blood loss
Time frame: Intraoperative
Overall survival, and disease-free survival
Time frame: At 1 and 3 years after LPG
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Northern Jiangsu People's Hospital