The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Primary Purpose
Pancreatic Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
Status
Active
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
pancreaticoduodenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatoduodenectomy, miniinvasive, complication, Morbidity, Mortality
Eligibility Criteria
Inclusion Criteria:
- Age: 21-75 years
- Clinically/histologically established diagnosis of the cancer;
- Preoperative imaging assessment is resectable or borderline resectable
Exclusion Criteria:
- Benign tumors of the head of pancreas;
- Distant metastasis;
- Conversion to laparotomy;
- Instrumental findings of the tumor process prevalence;
- General somatic status on the ASA III-V scale;
- Acute pancreatitis;
- Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)).
- Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection
Sites / Locations
- Ochapovsky Regional Clinical Hospital № 1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Laparoscopic Pancreaticoduodenectomy (LPD)
Robotic Pancreaticoduodenectomy (RPD)
Open Pancreaticoduodenectomy (OPD)
Arm Description
Outcomes
Primary Outcome Measures
Overall complications
The proportion of all complications after operation accounted for the total number of patients
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.
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.
Intra-abdominal infection
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Secondary Outcome Measures
Length of hospital stay (day)
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Full Information
NCT ID
NCT04763642
First Posted
February 13, 2021
Last Updated
April 19, 2023
Sponsor
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04763642
Brief Title
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Official Title
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
Keywords
pancreatoduodenectomy, miniinvasive, complication, Morbidity, Mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Pancreaticoduodenectomy (LPD)
Arm Type
Active Comparator
Arm Title
Robotic Pancreaticoduodenectomy (RPD)
Arm Type
Active Comparator
Arm Title
Open Pancreaticoduodenectomy (OPD)
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
pancreaticoduodenectomy
Intervention Description
Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation
Primary Outcome Measure Information:
Title
Overall complications
Description
The proportion of all complications after operation accounted for the total number of patients
Time Frame
up to 30 days
Title
Pancreatic fistula
Description
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.
Time Frame
up to 30 days
Title
Intra-abdominal bleeding
Description
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.
Time Frame
up to 30 days
Title
Intra-abdominal infection
Description
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Length of hospital stay (day)
Description
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Time Frame
Up to postoperative 2 months
Other Pre-specified Outcome Measures:
Title
progression-free survival
Description
The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason
Time Frame
Up to postoperative 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 21-75 years
Clinically/histologically established diagnosis of the cancer;
Preoperative imaging assessment is resectable or borderline resectable
Exclusion Criteria:
Benign tumors of the head of pancreas;
Distant metastasis;
Conversion to laparotomy;
Instrumental findings of the tumor process prevalence;
General somatic status on the ASA III-V scale;
Acute pancreatitis;
Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)).
Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection
Facility Information:
Facility Name
Ochapovsky Regional Clinical Hospital № 1
City
Krasnodar
State/Province
Krasnodar Region
ZIP/Postal Code
350068
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
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