Modified single-incision plus one-port laparoscopic pancreatoduodenectomy vs conventional five-port laparoscopic pancreatoduodenectomy for non-pancreatic periampullary cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares two laparoscopic approaches for non-pancreatic periampullary carcinomas: a modified single-incision plus one-port technique and the conventional five-port technique. Participants are adults up to 75 years old who require pancreaticoduodenectomy and have confirmed or highly suspected non-pancreatic periampullary cancer. The study uses a 1:1 randomization and blinded outcome assessment for complications and imaging, enrolling 232 participants. Primary outcomes are mortality within 90 days post-surgery and overall survival at 1 year; secondary outcomes include postoperative complications, surgical performance, recovery, disease-free survival, quality of life, and health-care costs.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Chenfenglin Yang
• Email: 15182546920@163.com
• Phone: +86 18583065665

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.