Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TJDBPS14 | Other Identifier | Tongji Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fudan University | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic pancreaticoduodenectomy | Experimental | laparoscopic pancreaticoduodenectomy |
|
| open pancreaticoduodenectomy | Active Comparator | open pancreaticoduodenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic pancreaticoduodenectomy | Procedure | laparoscopic pancreaticoduodenectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| length of hospital stay | defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year OS | 1 year OS | 1 year |
| Operative time | Total duration of the surgical procedure(minutes) | From enrollment to the end of operation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Renyi Qin | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42409398 | Derived | Li S, Pan S, Wang M, Huang X, Zhao W, Yu X, Chen X, Chen H, Dang X, Chen G, Wang L, An W, Zhang Q, Gao S, Guo S, Qin T, Zhang H, Qin R. Laparoscopic versus open pancreaticoduodenectomy for non-pancreatic periampullary adenocarcinomas: study protocol for a multicentre randomised controlled trial in China. BMJ Open. 2026 Jul 6;16(7):e117495. doi: 10.1136/bmjopen-2026-117495. |
Not provided
Not provided
Individual participant data will not be shared due to ethical restrictions approved by the ethics committees of all participating centres. The participant consent form did not include provisions for data sharing beyond the primary research team. The study protocol and statistical analysis plan are available as supplementary materials.
Not provided
Not provided
Not provided
Not provided
Not provided
| The Third Affiliated Hospital of Soochow University |
| OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Army Medical University, China | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| The First Affiliated Hospital of University of South China | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| Chongqing General Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| open pancreaticoduodenectomy | Procedure | open pancreaticoduodenectomy |
|
| Estimated blood loss | Intraoperative estimated blood loss volume(ml). | From enrollment to the end of operation |
| Intraoperative transfusion volume | Volume of blood products transfused during the operation(ml) | From enrollment to the end of operation |
| perioperative complication rate | proportion of patients experiencing postoperative complications) | 90 days |
| mortality rate and unplanned readmission rate | percentage of patients who die or require unplanned readmission within 90 days post-operation | 90 days |
| Karnofsky Performance Status (KPS) score | Functional status assessment. Scores range from 0 to 100, with higher scores indicating better functional status. Unit of Measure: score (0-100) | Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively |
| Eastern Cooperative Oncology Group (ECOG) performance status score | Functional status assessment. Scores range from 0 to 5, with lower scores indicating better functional status. Unit of Measure: score (0-5) | Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively |
| Surgical costs | Direct costs of the surgical procedure itself, including operating room fees, anesthesia fees, surgical supplies, and intraoperative medications. Unit of Measure: CNY | perioperatively |
| Total hospitalization expenses | Total inpatient costs from admission to discharge, including surgical costs, medications, bed charges, laboratory tests, imaging, nursing care, and other hospital services. Unit of Measure: CNY | perioperatively |