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2021-04-17
2024-04-30
2024-10-31
120
NCT05259384
Peking Union Medical College Hospital
Peking Union Medical College Hospital
INTERVENTIONAL
Robotic Versus 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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-04-21 | N/A | 2022-02-25 |
2022-02-25 | N/A | 2022-02-28 |
2022-02-28 | N/A | 2022-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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
|
| ACTIVE_COMPARATOR: MIPD-LAP Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy. | PROCEDURE: Laparoscopic pancreaticoduodenectomy
|
| EXPERIMENTAL: MIDP-ROB Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy. | PROCEDURE: Robotic Distal Pancreatectomy
|
| ACTIVE_COMPARATOR: MIDP-LAP Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy. | PROCEDURE: Laparoscopic Distal Pancreatectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Complication Rate | The rate of frequency of Clavein-Dindo Grade II-IV complication | up to 90 days |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Hanyu Zhang, M.D. Phone Number: 01069152600 Email: medzhy5813@126.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
