A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years old;
Pathologically confirmed as adenocarcinoma;
Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
Disqualifiers
Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
Pregnant or lactating women;
Patients with severe mental illness;
Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
Trial design
Design model
Single group
Treatments tested in this trial
Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
Procedure/SurgerySurgical Operation: 1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach. 2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection. 3. Anastomosis Method: esophagogastrostomy by fissure technique. 4. Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis. 5. Surgical Approach:Totally laparoscopic proximal gastrectomy.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assess intraoperative Perioperative Safety by Duration of surgery.
Time spent on the whole operation（minutes）
Time frame
intraoperative2
Assess intraoperative Perioperative Safety by Duration of anastomosis.
Time spent on the anastomosis in minutes
Time frame
intraoperative3
Assess intraoperative Perioperative Safety by blood loss .
Intraoperative blood loss in milliliters
Time frame
intraoperative4
Postoperative recovery course
Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Time frame
30 days after the surgerySecondary outcomes
1
The incidence of postoperative reflux esophagitis
Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
Time frame
3 months after surgery2
The incidence of postoperative anastomotic stenosis
Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
Time frame
3 months after surgery3
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30
QLQ-C30 is a comprehensive assessment of the overall quality of life dimensions before and after surgery for patients. Higher scores represent poorer quality of life for patients after surgery.
Time frame
3 months after surgery4
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale
QLQ-STO22 is a specific assessment for postoperative situations related to anastomosis, such as swallowing and eating.Higher scores represent poorer quality of life for patients after surgery.
Time frame
3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov