Overview
This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.
Eligibility
Inclusion Criteria:
- Age 18 years or older and younger than 75 years.
- Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.
- Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.
- Able to understand and comply with study procedures.
- Able and willing to provide written informed consent before any study-specific screening procedure.
- Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.
Exclusion Criteria:
- Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.
- Requirement for distal, central, or total pancreatectomy, or another palliative procedure.
- Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.
- Concurrent malignancy other than the target cancer.
- Pregnancy or breastfeeding.
- Severe psychiatric disorder that would interfere with study participation.
- Receipt of neoadjuvant chemotherapy or radiotherapy before surgery.
- Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging.
- Body mass index greater than 35 kg/m².
- Participation in another clinical trial within the previous 3 months.
