Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy
- Conditions
- Resectable Lesions Located in the Pancreatic Head or Periampullary Region
- Interventions
- Procedure: pancreatoduodenectomy
- Registration Number
- NCT05520606
- Lead Sponsor
- Tongji Hospital
- Brief Summary
This is a single, retrospective, real-world study to investigate the surgical outcomes of minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the perioperative characteristics and long-term overall survival being compared. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.
- Detailed Description
Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region.To date, how surgeons can safely pass the learning curve of laparoscopic pancreatoduodenectomy (LPD) without potentially harming patients remains a question. Around this topic, the investigators designed real-world study in a single center to retrospectively collect the PD surgeries since July 2014. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach. Besides, the investigators also want to investigate the clinical characteristics of patients and perioperative outcomes of LPD procedures and aimed to develop and validate a difficulty scoring system for patient selection which could help facilitate a comprehensive and security understanding of LPD for surgeon during different stage of the learning curve.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- Aged 18 to 80 years.
- Patients underwent PD surgeries.
- Peritoneal seeding or metastasis to distant sites;
- Incomplete clinical data.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description minimally invasive surgery pancreatoduodenectomy laparoscopic pancreatoduodenectomy. open surgery pancreatoduodenectomy open pancreatoduodenectomy
- Primary Outcome Measures
Name Time Method Postoperative length of stay up to 90 days defined as the time from being admitted to hospital to discharge
- Secondary Outcome Measures
Name Time Method Overall survival through study completion, an average of 5 year defined as the duration from the first day after surgery to either the date of death or the last follow-up
Intraoperative blood loss intraoperative recorded by the anesthetist using a vacuum system
Reoperation within 90 days up to 90 days defined as any reoperation within 90 days
Mortality up to 90 days defined as any death within 30 days and 90 days, respectively
Operation time intraoperative defined as the time from skin incision or trocar placement to complete skin closure
postoperative complications up to 90 days Postoperative complications were reviewed within 90 days after surgery and graded according to Clavien-Dindo (CD) classification system. Postoperative biliary leakage, hemorrhage, and liver failure. Wound infection was defined as purulent drainage from the incision or/and positive findings of culture of the fluid or tissue aseptically obtained from the incision.
R0 resection intraoperative defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins
Readmission within 90 days up to 90 days defined as any readmission within 90 days