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The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.
In the trial, 180 patients with proximal early gastric cancer will be enrolled and then randomly assigned to one of three groups: Group A (Kamikawa, n = 60), Group B (single-tract jejunal interposition, n = 60), or Group C (SOFY reconstruction, n = 60). The general information, past medical history, laboratory and imaging findings, and surgical procedures of each patient will be recorded. Patients in Group A, Group B and Group C will receive Kamikaze reconstruction, single-tract jejunal interposition reconstruction and SOFY reconstruction respectively after standard proximal gastrectomy and lymph nodes dissection. The primary endpoint will be the incidence of reflux esophagitis, while the incidence of anastomotic leakage, anastomotic stenosis, operative time, and intraoperative blood loss will be secondary endpoints to compare the efficacy of these three reconstruction methods after proximal gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kamikawa reconstruction | Experimental | Patients will be administered Kamikawa reconstruction after proximal gastrectomy. |
|
| STJI reconstruction | Active Comparator | Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy. |
|
| SOFY reconstruction | Active Comparator | Patients will be administered SOFY reconstruction after proximal gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kamikawa | Procedure | Kamikawa reconstruction after proximal gastrectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of reflux esophagitis | The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group. | 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of anastomotic leakage | The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group. | 14 days after surgery |
| incidence of anastomotic stenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr.Hu | Contact | +8613509754125 | beibeihejiyy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenqing Hu | Changzhi People's Hospital Affiliated to Changzhi Medical College | Study Chair |
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| STJI |
| Procedure |
Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy |
|
| SOFY | Procedure | SOFY reconstruction after proximal gastrectomy |
|
The percentage (%) of patients developing anastomotic stenosis after surgery in each group.
| 24 months after surgery |
| operative time | The duration, measured in minutes, spent on reconstructing the digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy. | 1 day after surgery |
| intraoperative blood loss | The amount of blood, measured in milliliters, lost during the reconstruction of digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy. | 1 day after surgery |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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