The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer; Bile Duct Cancer; Ampulla of Vater Cancer
• Intervention / Treatment: Procedure: pancreaticoduodenectomy

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).

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Krasnodar Region
    • Krasnodar, Krasnodar Region, Russian Federation, 350068
      • Ochapovsky Regional Clinical Hospital № 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Pancreaticoduodenectomy (LPD)	Procedure: pancreaticoduodenectomy; Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation
Active Comparator: Robotic Pancreaticoduodenectomy (RPD)	Procedure: pancreaticoduodenectomy; Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation
Placebo Comparator: Open Pancreaticoduodenectomy (OPD)	Procedure: pancreaticoduodenectomy; Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): April 19, 2023
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Morbidity; Mortality; complication; pancreatoduodenectomy; miniinvasive
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Biliary Tract Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Bile Duct Neoplasms
• Other Study ID Numbers: 20210202ORCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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