Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors

Phase

N/A

Condition

Primary Biliary Cholangitis

Abdominal Cancer

Pancreatic Cancer

Treatment

N/A

Clinical Study ID

NCT04400357

KY2020-93

Ages > 18
All Genders

Study Summary

This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with an indication for elective pancreaticoduodenectomy for malignant,premalignant, and symptomatic benign disease in the pancreatic and periampullaryregion
Performance status of 0/1 (assessed based on comorbidities using the Karnofsky scoreand Malnutrition Universal Screening Tool score among others, especially for patientswith malignant disease)
Imaging with computed tomography and/or MRI pancreas performed within 8 weeks forbenign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver,CT chest, and Cancer Antigen 19-9 is also mandatory.

Exclusion

Exclusion Criteria:

Body mass index > 35 kg/m2
Pregnancy
Previous history of major abdominal surgery
Requirement for multivisceral resection (additional surgical resection)
Preoperative chemotherapy and/or radiotherapy (for patients with pancreaticadenocarcinoma)
Involvement of major regional vessels by the tumor (portal and superior mesentericvein, superior mesenteric artery, hepatic artery, celiac artery) as defined by theborderline resectable and locally advanced nomenclature

Study Design

June 15, 2020

November 30, 2022

Study Description

The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that aims to address the question of feasibility and efficacy of the robotic minimally invasive approach in pancreaticoduodenectomy.

In the past 10 years there has been an increasing number of retrospective series from major centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple). The benefits of this minimally invasive approach appear to be decreased intraoperative estimated blood loss, lower postoperative pain levels and smaller length of hospital stay, whereas postoperative complications rates are comparable with the standard open approach.

This trial is conducted in multiple major centers for pancreatic surgery (open and robotic) in China and aims to address these questions in a prospective fashion. All eligible patients who present to these centers within the study period will be randomized in a 1:1 ratio to either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded regarding the type of the procedure by application of identical wound dressings at the trocar sites and the open incision. Patients will be followed up closely and will be evaluated routinely for quality of life parameters for a period of at least 2 years postoperatively. Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence and survival data.

Connect with a study center

Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200025
China
Active - Recruiting

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