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

RecruitingNAAges 18 Years - 75 YearsAllNanfang Hospital, Southern Medical University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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/mยฒ. * Participation in another clinical trial within the previous 3 months.
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What it tests

  • Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy
  • Conventional Laparoscopic Pancreaticoduodenectomy
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Where

4 sites
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
West China Hospital, Sichuan University
Chengdu, China
The People's Hospital of Jianyang City
Jiancheng, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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