Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Recruiting now · Not applicable

Conditions studied: Ampullary Carcinoma, Duodenal Adenocarcinoma, Distal Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT07744087

Run by

Nanfang Hospital, Southern Medical University

People needed

232

Starts

2026-06-04

Expected to finish

2029-12-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Chongqing, Chongqing Municipality, China (enrolling)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (enrolling)
• The People's Hospital of Jianyang City — Jiancheng, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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