Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

Study Overview
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Brief Summary
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Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Conventionally, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. In the ear of minimally invasive pancreatic surgery, when compared with open surgery, laparoscopic technology or Da Vinci robotic technology can avoid some open procedures limitations. Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures.

Detailed Description
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Background: Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. Its heterogeneity is large, which can be benign, borderline, and poor differentiation and even evolve into pancreatic cancer. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Some patients may be accompanied by recurrent pancreatitis, abdominal pain, nausea, vomiting, jaundice, and other gastrointestinal symptoms, usually with the help of abdominal ultrasound and endoscopy, ERCP, CT, nuclear magnetic, or MRCP imaging The examination can diagnose the disease. For PCN patients with large tumors, risk of malignant transformation, and accompanying symptoms that affect the quality of life, surgery is an effective treatment. Based on the conventional routine treatment, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. After more than 20 years of development, minimally invasive pancreatic surgery technology can be divided into two categories: laparoscopic technology and Da Vinci robotic technology. In general, compared with open surgery, minimally invasive pancreatic surgery technology can avoid some open procedures limitations, reduce the loss of intraoperative body fluid and its impact on the internal environment, and avoid excessive disturbance to other abdominal organs. It also helps reduce the pain of patients and shorten the length of hospital stay. Because most PCNs are benign or borderline tumors, such patients are eligible for minimally invasive pancreatic surgery. Aim and Hypothesis: Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures. We conduct a single-center prospective randomized clinical trial to compare the outcomes of different minimally invasive techniques.

Official Title
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Comparison Between Robotic and Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

Conditions
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Pancreatic Neoplasm

Intervention / Treatment
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* Procedure: Robotic pancreaticoduodenectomy
* Procedure: Laparoscopic pancreaticoduodenectomy
* Procedure: Robotic Distal Pancreatectomy
* Procedure: Laparoscopic Distal Pancreatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older; Diagnosed as PCN; Patients with head or neck PCNs are eligible for minimal invasive PD, or patients with distal PCNs are eligible for minimal invasive DP. Exclusion Criteria: Not a PCN base on the sample's pathology; Procedure change from MIDP/MIPD to others during the operation; ASA more than 4; Patients or families deny certain treatment.

Ages Eligible for Study
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Minimum Age: 18 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: The enrolled candidates will be split into two subgroups(PD group or DP group) based on the location of their neoplasms. Every subgroups will be divided into two parallel groups by the randomization of intervention plan(lap surgery or robotic surgery)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIPD-ROB<br>Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy. | Procedure: Robotic pancreaticoduodenectomy<br>* The Intervention of MIPD-ROB group<br>|
| Active Comparator: MIPD-LAP<br>Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy. | Procedure: Laparoscopic pancreaticoduodenectomy<br>* The Intervention of MIPD-LAP group<br>|
| Experimental: MIDP-ROB<br>Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy. | Procedure: Robotic Distal Pancreatectomy<br>* The Intervention of MIDP-ROB group<br>|
| Active Comparator: MIDP-LAP<br>Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy. | Procedure: Laparoscopic Distal Pancreatectomy<br>* The Intervention of MIDP-LAP group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | The rate of frequency of Clavein-Dindo Grade II-IV complication | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay | The mean of postoperative length of stay | during the treatment | 
| VAS score | patients complain of pain after surgery, 0-10, 10 means the greatest pain | up to 90 days | 
| Grade B and C pancreatic fistula | The frequency of grade B or C pancreatic fistula | up to 90 days | 
| QOL score | Quality of life after surgery, greater means higher life satisfaction | up to 90 days | 
| Expense | The amount of treatment expense and certain procedure expense | during the treatment | 
| 90-day death rate | The rate of death within 90 days after surgery | up to 90 days | 
| The rate of spleen-preservation | For DP groups, the rate of spleen being preserved | up to 90 days |