Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial

Study Overview
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Brief Summary
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Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.

Detailed Description
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This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic 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 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.

Official Title
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Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial

Conditions
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Pancreatoduodenectomy

Intervention / Treatment
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* Procedure: 3D Laparoscopic pancreatoduodenectomy
* Procedure: 2D Laparoscopic pancreatoduodenectomy


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
Interventional Model Description: Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D Laparoscopic pancreatoduodenectomy<br>Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy | Procedure: 2D Laparoscopic pancreatoduodenectomy<br>* 2D Laparoscopic pancreatoduodenectomy<br>|
| Experimental: 3D Laparoscopic pancreatoduodenectomy<br>Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy | Procedure: 3D Laparoscopic pancreatoduodenectomy<br>* Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | overall survival duration after surgical treatment | 60 month | 

Secondary 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2D and 3D Laparoscopic pancreatoduodenectomy