A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique (NCT06300879) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
China30 participantsStarted 2024-01-01
Plain-language summary
This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).
The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Age between 18 and 75 years old;
ā. Pathologically confirmed as adenocarcinoma;
ā. Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
ā. If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
ā. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
ā. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
ā. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
ā. No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
Exclusion criteria
ā. Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
What they're measuring
1
Assess intraoperative Perioperative Safety by Duration of surgery.
Timeframe: intraoperative
2
Assess intraoperative Perioperative Safety by Duration of anastomosis.
Timeframe: intraoperative
3
Assess intraoperative Perioperative Safety by blood loss .
Timeframe: intraoperative
4
Postoperative recovery course
Timeframe: 30 days after the surgery
5
Postoperative TNM staging by Pathological findings .