2020-01-01
2023-04-19
2025-01-01
320
NCT04763642
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
INTERVENTIONAL
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons. Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial. In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as "open" proximal pancreatoduodenectomy (OPD).
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 |
|---|---|---|
2021-02-13 | N/A | 2024-06-20 |
2021-02-18 | N/A | 2024-06-24 |
2021-02-21 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Laparoscopic Pancreaticoduodenectomy (LPD) | PROCEDURE: pancreaticoduodenectomy
|
| ACTIVE_COMPARATOR: Robotic Pancreaticoduodenectomy (RPD) | PROCEDURE: pancreaticoduodenectomy
|
| PLACEBO_COMPARATOR: Open Pancreaticoduodenectomy (OPD) | PROCEDURE: pancreaticoduodenectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall complications | The proportion of all complications after operation accounted for the total number of patients | up to 30 days |
| Pancreatic fistula | The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course. | up to 30 days |
| Intra-abdominal bleeding | he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration. | up to 30 days |
| Intra-abdominal infection | Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test. | up to 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Length of hospital stay (day) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Up to postoperative 2 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
21 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
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