NCT07744087Recruiting
Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 27 Jul 2026
- Start date
- 4 Jun 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07744087
What you commit to
- Study type: Interventional
- Planned participants: 232
- From 4 Jun 2026 to the primary completion date, 30 Jun 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent malignancy other than the target cancer.
- Receipt of neoadjuvant chemotherapy or radiotherapy before surgery.
- Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging.
- Participation in another clinical trial within the previous 3 months.
Other illness
- Severe psychiatric disorder that would interfere with study participation.
Other
- 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.
- Pregnancy or breastfeeding.
- Body mass index greater than 35 kg/m².
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The People's Hospital of Jianyang City Coordinator of this site? Confirm its status | Jiancheng | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.