Clinical trial NCT05259384: Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms
Official title: Comparison Between Robotic and Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasm
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complication Rate
timeFrame: up to 90 days
Secondary outcomes:
measure: Postoperative length of stay
timeFrame: during the treatment
measure: VAS score
timeFrame: up to 90 days
measure: Grade B and C pancreatic fistula
timeFrame: up to 90 days
measure: QOL score
timeFrame: up to 90 days
measure: Expense
timeFrame: during the treatment
measure: 90-day death rate
timeFrame: up to 90 days
measure: The rate of spleen-preservation
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
name: MENGHUA Dai, M.D.
role: STUDY_CHAIR
References: