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Pancreatin

Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy.

Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy.

Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy.

Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy.

Robotic pancreaticoduodenectomy

Laparoscopic pancreaticoduodenectomy

Robotic Distal Pancreatectomy

Laparoscopic Distal Pancreatectomy

Hanyu Zhang, M.D.

Menghua Dai, M.D.

MENGHUA Dai, M.D.

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.

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.

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)

Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

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

The rate of frequency of Clavein-Dindo Grade II-IV complication

patients complain of pain after surgery, 0-10, 10 means the greatest pain

The frequency of grade B or C pancreatic fistula

Quality of life after surgery, greater means higher life satisfaction

The amount of treatment expense and certain procedure expense

The rate of death within 90 days after surgery

For DP groups, the rate of spleen being preserved

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms	NCT05259384	Pancreatic Neop...	Robotic pancrea... Laparoscopic pa... Robotic Distal ... Laparoscopic Di...	18 Years -	Peking Union Medical College Hospital
Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms	NCT05259384	Pancreatic Neop...	Robotic pancrea... Laparoscopic pa... Robotic Distal ... Laparoscopic Di...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for robotic distal pancreatectomy