Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduod… (NCT07744087) | Clinical Trial Compass
RecruitingNot Applicable
Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
China232 participantsStarted 2026-06-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival Rate at 1 Year After Surgery
Timeframe: From the date of surgery to 1 year after surgery
2
All-Cause Mortality Within 90 Days After Surgery
Timeframe: From surgery through 90 days after surgery
Trial details
NCT IDNCT07744087
SponsorNanfang Hospital, Southern Medical University