Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

Pancreatic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259384
• Other study ID #: Daimh-ROBOTIC-PCN
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2022
• Source: Peking Union Medical College Hospital
• Contact: Hanyu Zhang, M.D.
• Phone: 01069152600
• Email: medzhy5813[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Procedure:
• Robotic pancreaticoduodenectomy
The Intervention of MIPD-ROB group
• Laparoscopic pancreaticoduodenectomy
The Intervention of MIPD-LAP group
• Robotic Distal Pancreatectomy
The Intervention of MIDP-ROB group
• Laparoscopic Distal Pancreatectomy
The Intervention of MIDP-LAP group

Locations

Country	Name	City	State
China	Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rate	The rate of frequency of Clavein-Dindo Grade II-IV complication	up to 90 days
Secondary	Postoperative length of stay	The mean of postoperative length of stay	during the treatment
Secondary	VAS score	patients complain of pain after surgery, 0-10, 10 means the greatest pain	up to 90 days
Secondary	Grade B and C pancreatic fistula	The frequency of grade B or C pancreatic fistula	up to 90 days
Secondary	QOL score	Quality of life after surgery, greater means higher life satisfaction	up to 90 days
Secondary	Expense	The amount of treatment expense and certain procedure expense	during the treatment
Secondary	90-day death rate	The rate of death within 90 days after surgery	up to 90 days
Secondary	The rate of spleen-preservation	For DP groups, the rate of spleen being preserved	up to 90 days