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Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

RecruitingNAAges 18 Years - 75 YearsAllTongji Hospital
NCT03785743 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required. Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhan

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 years and 75 years. 2. Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence. 3. Patients feasible to undergo both LPD and OPD according to MDT evaluations. 4. Patients understanding and willing to comply with this trial. 5. Provision of written informed consent before patient registration. 6. Patients meeting the curative treatment intent in accordance with clinical guidelines. Exclusion Criteria: 1. Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs. 2. Patients requiring left, central or total pancreatectomy or other palliative surgery. 3. Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4. 4. History of other malignant disease. 5. Pregnant or breast-feeding women. 6. Patients with serious mental disorders. 7. Patients treated with neoadjuvant therapy. 8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data. 9. Body mass index \> 35 kg/m2. 10. Patients participating in any other clinical trials within 3 months.
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What it tests

  • TLPD Surgery
  • OPD Surgery
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Where

1 site
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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