The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer

Study Overview
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Brief Summary
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Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.

Detailed Description
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This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.

Official Title
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The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial

Conditions
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Pancreatic Carcinoma, Surgery

Intervention / Treatment
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* Procedure: Minimally-invasive pancreaticoduodenectomy
* Other: Open pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: >18yr, <75yr Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy Preoperative imaging assessment is resectable or borderline resectable Exclusion Criteria: Benign tumors of the head of pancreas Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis. conversion to laparotomy because of intraoperative difficulty

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally-invasive Pancreaticoduodenectomy<br>MIPD | Procedure: Minimally-invasive pancreaticoduodenectomy<br>* Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor<br>|
| Placebo Comparator: Open Pancreaticoduodenectomy<br>OPD | Other: Open pancreaticoduodenectomy<br>* Open pancreaticoduodenectomy for resection of pancreatic tumor<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 postoperative 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 postoperative 30 days | 
| Intra-abdominal bleeding | The 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 postoperative 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 postoperative 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 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimally-invasive pancreaticoduodenectomy, open pancreaticoduodenectomy, pancreatic cancer