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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique | Procedure | Surgical Operation:
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess intraoperative Perioperative Safety by Duration of surgery. | Time spent on the whole operation(minutes) | intraoperative |
| Assess intraoperative Perioperative Safety by Duration of anastomosis. | Time spent on the anastomosis in minutes | intraoperative |
| Assess intraoperative Perioperative Safety by blood loss . | Intraoperative blood loss in milliliters | intraoperative |
| 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. | 30 days after the surgery |
| Postoperative TNM staging by Pathological findings . | AJCC(American Joint Committee on Cancer)-8th TNM staging system will be used to obtain pathology of tumor . | 30 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after surgery |
| The incidence of postoperative anastomotic stenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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|
Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination |
| 3 months after surgery |
| 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. | 3 months after surgery |
| 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. | 3 months after surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |