A Prospective Clinical Study Using an Artery-first Intermediate Approach in Robot-assisted Pancreaticoduodenectomy

NCT05660915 | Recruiting DMC

• 1 other identifier: USC-4310-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreaticoduodenectomy, as a standard surgical procedure for malignant tumors of the head of the pancreas, ampulla and distal common bile duct, has brought the hope of clinical cure for these diseases.In the whole surgical process, the resection of the uncinate process of the pancreas is considered to be a major difficulty in the whole operation, which can affect the rehabilitation process and long-term prognosis. Two main methods have been developed around the dissection of the uncinate process of the pancreas. One is the Venous-first approach based on the portal vein-superior mesenteric vein axis. The other is the Artery-first approach that first explores whether the superior mesenteric artery is invaded by the tumor to judge resectable. The latter is gradually promoted in clinical practice because it can reduce intraoperative bleeding, reduce postoperative complications, and improve long-term prognosis. The intermediate approach is a surgical approach based on the Artery-first approach and adapted to the layout of the robot arm. The area between superior mesenteric artery and superior mesenteric vein was used as an intermediate area to treat the uncinate process of the pancreas in order to reduce perioperative complications and achieve better surgical results. However, the safety and effectiveness of intermediate approach have not been verified,in this prospective clinical study, the investigators will use a robotic surgical platform to perform robot-assisted pancreaticoduodenectomy surgery through the intermediate approach to verify its safety and efficacy.

Conditions

Pancreatic Cancer; Common Bile Duct Diseases; Periampullary Carcinoma

Keywords

Robot-assisted pancreaticoduodenectomy; Superior mesenteric artery first approach; Intermediate approach; Safety and Efficacy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Rate of mortality after surgery

  The short-term prognosis of this procedure will be evaluated by recording patient mortality during hospitalization, 30 days and 90 days after surgery.

  5 months

Secondary Outcomes (2)

• Unplanned re-admission rate after discharge within 30 days

  3 months

• Incidence of postoperative complications

  2 months

Study Arms (2)

The intermediate approach

EXPERIMENTAL

The key point of surgery in the standard approach group was to first reveal portal vein-superior mesenteric vein and gradually complete the resection of the uncinate process of pancreas based on the reference of portal vein-superior mesenteric vein.

Procedure: Intermediate approach

The standard approach

OTHER

The area between superior mesenteric artery and superior mesenteric vein was defined as the intermediate area and dissection was performed in this area to achieve the removal of the uncinate process of pancreas.

Procedure: Standard approach

Interventions

Intermediate approach PROCEDURE

The area between superior mesenteric vein and superior mesenteric artery was defined as the intermediate area and dissection was performed in this area to achieve the removal of the uncinate process of pancreas.

The intermediate approach

Standard approach PROCEDURE

The key point of surgery in the standard approach group was to first reveal portal vein-superior mesenteric vein and gradually complete the the resection of the uncinate process of pancreas based on the reference of portal vein-superior mesenteric vein.

The standard approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy
• No obvious arterial invasion, no obvious venous invasion or vein invasion but can be replaced
• No distant transfer
• Complete clinical data

You may not qualify if:

• With tumors of other organs
• Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs
• Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery
• Preoperative adjuvant therapy was given
• Clinical data are seriously missing

Sponsors & Collaborators

• The First Affiliated Hospital of University of South China: lead

Study Sites (1)

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Common Bile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Guodong Chen, PhD

  The First Affiliated Hospital of University of South China

  STUDY CHAIR

Central Study Contacts

Guodong Chen, PhD

CONTACT

(+86)15211450345; Chenguodong@usc.edu.cn

Danjun Chen, PhD

CONTACT

(+86)13789353900; nhfykyb@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The way of surgery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The key point of surgery in the standard approach group was to first reveal portal vein-superior mesenteric vein and gradually complete the resection of the uncinate process of pancreas based on the reference of portal vein-superior mesenteric vein.In the intermediate approach group, the area between superior mesenteric artery and superior mesenteric vein was defined as the intermediate area and dissection was performed in this area to achieve the removal of the uncinate process of pancreas. Subsequently, data related to intraoperative conditions (such as operation time, amount of blood loss, etc.) and postoperative complications were collected and statistically analyzed to verify the safety of the intermediate approach, and short-term prognostic data was collected to verify its effectiveness.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 21, 2022
• Study Start: June 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)