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Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

NCT ID: NCT05259384

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-17

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIPD-ROB

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

Group Type EXPERIMENTAL

Robotic pancreaticoduodenectomy

Intervention Type PROCEDURE

The Intervention of MIPD-ROB group

MIPD-LAP

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

Group Type ACTIVE_COMPARATOR

Laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

The Intervention of MIPD-LAP group

MIDP-ROB

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

Group Type EXPERIMENTAL

Robotic Distal Pancreatectomy

Intervention Type PROCEDURE

The Intervention of MIDP-ROB group

MIDP-LAP

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

Group Type ACTIVE_COMPARATOR

Laparoscopic Distal Pancreatectomy

Intervention Type PROCEDURE

The Intervention of MIDP-LAP group

Interventions

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Robotic pancreaticoduodenectomy

The Intervention of MIPD-ROB group

Intervention Type PROCEDURE

Laparoscopic pancreaticoduodenectomy

The Intervention of MIPD-LAP group

Intervention Type PROCEDURE

Robotic Distal Pancreatectomy

The Intervention of MIDP-ROB group

Intervention Type PROCEDURE

Laparoscopic Distal Pancreatectomy

The Intervention of MIDP-LAP group

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MENGHUA Dai, M.D.

Role: STUDY_CHAIR

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hanyu Zhang, M.D.

Role: CONTACT

Phone: 01069152600

Email: [email protected]

Facility Contacts

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Menghua Dai, M.D.

Role: primary

Other Identifiers

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Daimh-ROBOTIC-PCN

Identifier Type: -

Identifier Source: org_study_id