Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy
- Conditions
- Pancreatic Ductal AdenocarcinomaSurgeryPeriampullary Cancer
- Interventions
- Procedure: Total laparoscopic pancreaticoduodenectomyProcedure: Open pancreaticoduodenectomy
- Registration Number
- NCT03138213
- Lead Sponsor
- Tongji Hospital
- Brief Summary
Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomized controlled trials (RCTs) are lacking but are clearly required.
Methods and analysis TJDBPS01 is a multicentre, prospective, randomized controlled, parallel-group, superiority trial in fourteen centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay (LOS).
Ethics and dissemination The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organization. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 656
- Histologically proven periampullary cancer, including pancreatic cancer, bile duct cancer, duodenal cancer, et al.
- Highly presumed malignancy with difficulties to obtain histological evidence.
- Preoperative staging work up performed by upper abdomen enhanced CT scan.
- The subject understands the nature of this trial and willing to comply.
- Ability to provide written informed consent.
- Patients treated with curative intent in accordance to international guidelines
- Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
- Subjects undergoing left, central or total pancreatectomy.
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.
- Synchronous malignancy in other organs.
- Previous underwent pancreatic resections.
- Palliative surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TLPD Total laparoscopic pancreaticoduodenectomy Ttotal laparoscopic pancreaticoduodenectomy OPD Open pancreaticoduodenectomy Open pancreaticoduodenectomy
- Primary Outcome Measures
Name Time Method Length of stay Up to 24 months Length of stay was defined as the postoperative time interval in days
- Secondary Outcome Measures
Name Time Method Mortality Up to 24 months Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
Estimated blood loss Up to 24 months The amount of blood loss during surgical procedure.
Operation time Up to 24 months Time between first incision and last skin closure.
CCI Up to 24 months comprehensive complication index
Complication rate Up to 24 months Clavien-Dindo
2 year survival Up to 24 months Overall survival rate for 24 months after surgery
Trial Locations
- Locations (1)
Tongji Hospital
🇨🇳Wuhan, Hubei, China