The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

NCT ID: NCT04763642

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-04-30

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).

Conditions

Pancreatic Cancer; Bile Duct Cancer; Ampulla of Vater Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Pancreaticoduodenectomy (LPD)

Group Type: ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type: PROCEDURE

Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

Robotic Pancreaticoduodenectomy (RPD)

Group Type: ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type: PROCEDURE

Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

Open Pancreaticoduodenectomy (OPD)

Group Type: PLACEBO_COMPARATOR

pancreaticoduodenectomy

Intervention Type: PROCEDURE

Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

Interventions

pancreaticoduodenectomy

Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ochapovsky Regional Clinical Hospital № 1

Krasnodar, Krasnodarskiy Kray, Russia

Countries

Russia

Other Identifiers

20210202ORCH

Identifier Type: -

Identifier Source: org_study_id