Periampullary Adenocarcinoma
Conditions
Keywords
non-pancreatic periampullary adenocarcinoma, laparoscopic pancreaticoduodenectomy
Brief summary
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
Detailed description
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
Interventions
PROCEDURElaparoscopic pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy
PROCEDUREopen pancreaticoduodenectomy
open pancreaticoduodenectomy
Sponsors
Tongji Hospital
Fudan University
The First Affiliated Hospital of Dalian Medical University
The Affiliated Hospital of Xuzhou Medical University
The Third Affiliated Hospital of Soochow University
Shanxi Province Cancer Hospital
Army Medical University, China
Qilu Hospital of Shandong University
Nanfang Hospital, Southern Medical University
The First Affiliated Hospital of University of South China
First Affiliated Hospital of Harbin Medical University
Chongqing General Hospital
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 years and 75 years. 2. Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence. 3. Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations. 4. Patients understanding and willing to comply with this trial. 5. Provision of written informed consent before patient registration. 6. Patients meeting the curative treatment intent in ac- cordance with clinical guidelines.
Exclusion criteria
1. Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs. 2. Patients requiring left, central or total pancreatecto- my or other palliative surgery. 3. Preoperative American Society of Anaesthesiologists (ASA) score ≥4. 4. History of other malignant disease 5. Pregnant or breastfeeding women. 6. Patients with serious mental disorders 7. Patients treated with neoadjuvant therapy. 8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data. 9. Body mass index \>35 kg/m 2 . 10. Patients participating in any other clinical trials with- in 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | 90 days | defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 year OS | 1 year | 1 year OS |
| Operative time | From enrollment to the end of operation | Total duration of the surgical procedure(minutes) |
| Estimated blood loss | From enrollment to the end of operation | Intraoperative estimated blood loss volume(ml). |
| Intraoperative transfusion volume | From enrollment to the end of operation | Volume of blood products transfused during the operation(ml) |
| perioperative complication rate | 90 days | proportion of patients experiencing postoperative complications) |
| mortality rate and unplanned readmission rate | 90 days | percentage of patients who die or require unplanned readmission within 90 days post-operation |
| Karnofsky Performance Status (KPS) score | Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively | Functional status assessment. Scores range from 0 to 100, with higher scores indicating better functional status. Unit of Measure: score (0-100) |
| Eastern Cooperative Oncology Group (ECOG) performance status score | Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively | Functional status assessment. Scores range from 0 to 5, with lower scores indicating better functional status. Unit of Measure: score (0-5) |
| Surgical costs | perioperatively | Direct costs of the surgical procedure itself, including operating room fees, anesthesia fees, surgical supplies, and intraoperative medications. Unit of Measure: CNY |
| Total hospitalization expenses | perioperatively | 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORRenyi Qin
Tongji Hospital
Outcome results
None listed