Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Location status: Recruiting
NCT Number: NCT06300879
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200040, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical Operation:
Time frame: intraoperative
Time spent on the whole operation(minutes)
Time frame: intraoperative
Time spent on the anastomosis in minutes
Time frame: intraoperative
Intraoperative blood loss in milliliters
Time frame: 30 days after the surgery
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 surgery
AJCC(American Joint Committee on Cancer)-8th TNM staging system will be used to obtain pathology of tumor .
Time frame: 3 months after surgery
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 surgery
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 surgery
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 surgery
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.
Huashan Hospital
Other
A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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