histologically confirmed periampullary carcinoma of non-pancreatic origin, or those highly suspected of having periampullary carcinoma of non-pancreatic origin when histological evidence is unavailable.
Conditions
Interventions
SILPD+1 Group:Modified Single Incision plus one?port Laparoscopic Pancreaticoduodenectomy
CLPD Group:Conventional Laparoscopic Pancreaticoduodenectomy
Sponsors
Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged = 18 years and < 75 years; 2.Histopathologically confirmed non-pancreatic periampullary carcinoma, or highly suspected non-pancreatic periampullary carcinoma without pathological evidence; 3.Patients who have been determined by preoperative MDT evaluation to require pancreaticoduodenectomy; 4.The subject understands and is able to cooperate with this study; 5.The subject is able to provide and sign written informed consent prior to performing any study-related screening procedures; 6.Patients who will benefit from this therapeutic surgery according to NCCN and other relevant guidelines;
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastases, including peritoneal, hepatic, distant lymph node metastases, and involvement of other organs; 2. Patients requiring left, middle, or total pancreatectomy or other palliative procedures; 3. Preoperative American Society of Anesthesiologists (ASA) score >= 4; 4. Patients with concurrent other malignant tumors; 5. Pregnant or lactating women; 6. Patients with severe mental disorders; 7. Patients who have received neoadjuvant chemoradiotherapy before surgery; 8. Patients with vascular invasion requiring vascular resection as assessed by the MDT team based on abdominal imaging data; 9. Body mass index (BMI) > 35 kg/m^2; 10. Participation in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival (OS) rate after surgery;90-day postoperative mortality (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day overall complication rate after surgery;R0 resection rate;Operative time;1-year disease-free survival (DFS) rate after surgery;Conversion rate to open surgery;Postoperative length of stay (LOS); | — |
Countries
China
Contacts
Public ContactZhang Qifan
Nanfang Hospital, Southern Medical University
Outcome results
None listed