The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Pancreatic Cancer Clinical Trial

Official title:

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04763642
• Other study ID #: 20210202ORCH
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2023
• Source: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: January 1, 2025
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ampulla of Vater Cancer
• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Pancreatic Cancer

Intervention

Procedure:
• pancreaticoduodenectomy
Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

Locations

Country	Name	City	State
Russian Federation	Ochapovsky Regional Clinical Hospital ? 1	Krasnodar	Krasnodar Region

Sponsors (1)

Lead Sponsor	Collaborator
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	progression-free survival	The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason	Up to postoperative 3 years
Primary	Overall complications	The proportion of all complications after operation accounted for the total number of patients	up to 30 days
Primary	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
Primary	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
Primary	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	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