protocolSection identificationModule nctId: NCT06300879, orgStudyIdInfo id: 2023-1058, briefTitle: A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Huashan Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Gastric Cancer, conditions: Adenocarcinoma of Esophagogastric Junction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique, outcomesModule primaryOutcomes measure: Assess intraoperative Perioperative Safety by Duration of surgery., primaryOutcomes measure: Assess intraoperative Perioperative Safety by Duration of anastomosis., primaryOutcomes measure: Assess intraoperative Perioperative Safety by blood loss ., primaryOutcomes measure: Postoperative recovery course, primaryOutcomes measure: Postoperative TNM staging by Pathological findings ., secondaryOutcomes measure: The incidence of postoperative reflux esophagitis, secondaryOutcomes measure: The incidence of postoperative anastomotic stenosis, secondaryOutcomes measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30, secondaryOutcomes measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huashan Hospital, Fudan University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Hankun Hao, doctor, role: CONTACT, phone: +86 18121186328, email: haohankun@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False