Clinical trial NCT04763642: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Bile Duct Cancer
Ampulla of Vater Cancer
Keywords: pancreatoduodenectomy
miniinvasive
complication
Morbidity
Mortality
Lead sponsor: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-21
Enrollment: 320
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Overall complications
timeFrame: up to 30 days
measure: Pancreatic fistula
timeFrame: up to 30 days
measure: Intra-abdominal bleeding
timeFrame: up to 30 days
measure: Intra-abdominal infection
timeFrame: up to 30 days
Secondary outcomes:
measure: Length of hospital stay (day)
timeFrame: Up to postoperative 2 months
Other outcomes:
measure: progression-free survival
timeFrame: Up to postoperative 3 years
Locations:
city: Krasnodar
country: Russian Federation
facility: Ochapovsky Regional Clinical Hospital № 1
state: Krasnodar Region
Study officials:
References: