Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasm
• Intervention / Treatment: Procedure: Robotic pancreaticoduodenectomy; Procedure: Laparoscopic pancreaticoduodenectomy; Procedure: Robotic Distal Pancreatectomy; Procedure: Laparoscopic Distal Pancreatectomy

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MIPD-ROB; Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy.	Procedure: Robotic pancreaticoduodenectomy; The Intervention of MIPD-ROB group
ACTIVE_COMPARATOR: MIPD-LAP; Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy.	Procedure: Laparoscopic pancreaticoduodenectomy; The Intervention of MIPD-LAP group
EXPERIMENTAL: MIDP-ROB; Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy.	Procedure: Robotic Distal Pancreatectomy; The Intervention of MIDP-ROB group
ACTIVE_COMPARATOR: MIDP-LAP; Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy.	Procedure: Laparoscopic Distal Pancreatectomy; The Intervention of MIDP-LAP group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: MENGHUA Dai, M.D., Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2021
• Primary Completion (ANTICIPATED): April 30, 2024
• Study Completion (ANTICIPATED): October 31, 2024

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (ACTUAL): February 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: Daimh-ROBOTIC-PCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No