Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

NCT05259384 | Unknown

• 1 other identifier: Daimh-ROBOTIC-PCN
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Complication Rate

  The rate of frequency of Clavein-Dindo Grade II-IV complication

  up to 90 days

Secondary Outcomes (7)

• Postoperative length of stay

  during the treatment

• VAS score

  up to 90 days

• Grade B and C pancreatic fistula

  up to 90 days

• QOL score

  up to 90 days

• Expense

  during the treatment

Study Arms (4)

MIPD-ROB

EXPERIMENTAL

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

Procedure: Robotic pancreaticoduodenectomy

MIPD-LAP

ACTIVE COMPARATOR

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

Procedure: Laparoscopic pancreaticoduodenectomy

MIDP-ROB

EXPERIMENTAL

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

Procedure: Robotic Distal Pancreatectomy

MIDP-LAP

ACTIVE COMPARATOR

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

Procedure: Laparoscopic Distal Pancreatectomy

Interventions

Robotic pancreaticoduodenectomy PROCEDURE

The Intervention of MIPD-ROB group

MIPD-ROB

Laparoscopic pancreaticoduodenectomy PROCEDURE

The Intervention of MIPD-LAP group

MIPD-LAP

Robotic Distal Pancreatectomy PROCEDURE

The Intervention of MIDP-ROB group

MIDP-ROB

Laparoscopic Distal Pancreatectomy PROCEDURE

The Intervention of MIDP-LAP group

MIDP-LAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older;
• Diagnosed as PCN;
• Patients with head or neck PCNs are eligible for minimal invasive PD, or patients with distal PCNs are eligible for minimal invasive DP.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

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

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• MENGHUA Dai, M.D.

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

  STUDY CHAIR

Central Study Contacts

Hanyu Zhang, M.D.

CONTACT

01069152600; medzhy5813@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: February 28, 2022
• Study Start: April 17, 2021
• Primary Completion: April 30, 2024
• Study Completion: October 31, 2024
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)