Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

Not Applicable

Recruiting

• Conditions: Pancreatic Neoplasm
• Interventions: Procedure: Robotic pancreaticoduodenectomy; Procedure: Laparoscopic pancreaticoduodenectomy; Procedure: Robotic Distal Pancreatectomy; Procedure: Laparoscopic Distal Pancreatectomy

• Registration Number: NCT05259384
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-17
• Study First Submitted: 2021-04-21
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Primary Completion: 2024-04-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 18 years old or older;
2. Diagnosed as PCN;
3. 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

1. Not a PCN base on the sample's pathology;
2. Procedure change from MIDP/MIPD to others during the operation;
3. ASA more than 4;
4. Patients or families deny certain treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIPD-ROB	Robotic pancreaticoduodenectomy	Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy.
MIPD-LAP	Laparoscopic pancreaticoduodenectomy	Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy.
MIDP-ROB	Robotic Distal Pancreatectomy	Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy.
MIDP-LAP	Laparoscopic Distal Pancreatectomy	Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy.

Primary Outcome Measures

Name	Time	Method
Complication Rate	up to 90 days	The rate of frequency of Clavein-Dindo Grade II-IV complication

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; 🇨🇳 Beijing, China