The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Study Overview
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Brief Summary
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The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Detailed Description
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Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons. Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial. In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as open proximal pancreatoduodenectomy (OPD).

Official Title
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The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Conditions
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Pancreatic Cancer, Bile Duct Cancer, Ampulla of Vater Cancer

Intervention / Treatment
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* Procedure: pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 21-75 years Clinically/histologically established diagnosis of the cancer; Preoperative imaging assessment is resectable or borderline resectable Exclusion Criteria: Benign tumors of the head of pancreas; Distant metastasis; Conversion to laparotomy; Instrumental findings of the tumor process prevalence; General somatic status on the ASA III-V scale; Acute pancreatitis; Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)). Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection

Ages Eligible for Study
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Minimum Age: 21 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Pancreaticoduodenectomy (LPD)<br> | Procedure: pancreaticoduodenectomy<br>* Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation<br>|
| Active Comparator: Robotic Pancreaticoduodenectomy (RPD)<br> | Procedure: pancreaticoduodenectomy<br>* Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation<br>|
| Placebo Comparator: Open Pancreaticoduodenectomy (OPD)<br> | Procedure: pancreaticoduodenectomy<br>* Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complications | The proportion of all complications after operation accounted for the total number of patients | up to 30 days | 
| Pancreatic fistula | The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course. | up to 30 days | 
| Intra-abdominal bleeding | he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration. | up to 30 days | 
| Intra-abdominal infection | Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test. | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (day) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Up to postoperative 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatoduodenectomy, miniinvasive, complication, Morbidity, Mortality