Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Minimally Invasive Versus Open for Pancreatoduodenectomy：an Retrospective, Observational, Multicenter Real-world Study

Conditions
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Resectable Lesions Located in the Pancreatic Head or Periampullary Region

Intervention / Treatment
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* Procedure: pancreatoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years. Patients underwent PD surgeries. Exclusion Criteria: Peritoneal seeding or metastasis to distant sites; Incomplete clinical data.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| minimally invasive surgery<br>laparoscopic pancreatoduodenectomy. | Procedure: pancreatoduodenectomy<br>* 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<br>|
| open surgery<br>open pancreatoduodenectomy | Procedure: pancreatoduodenectomy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay | defined as the time from being admitted to hospital to discharge | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | defined as the duration from the first day after surgery to either the date of death or the last follow-up | through study completion, an average of 5 year | 
| Operation time | defined as the time from skin incision or trocar placement to complete skin closure | intraoperative | 
| postoperative complications | 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. | up to 90 days | 
| Reoperation within 90 days | defined as any reoperation within 90 days | up to 90 days | 
| Mortality | defined as any death within 30 days and 90 days, respectively | up to 90 days | 
| Readmission within 90 days | defined as any readmission within 90 days | up to 90 days | 
| R0 resection | defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins | intraoperative | 
| Intraoperative blood loss | recorded by the anesthetist using a vacuum system | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic, minimally invasive, open resection, Pancreatoduodenectomy