Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL)

Shanghai Jiao Tong University

Status: Completed

Conditions: Chronic Pancreatitis; Ampullary Adenocarcinoma; Cholangiocarcinoma, Extrahepatic; Pancreatic Adenocarcinoma; Pancreatic Endocrine Tumors; Pancreatic Cysts; Duodenal Adenocarcinoma

Treatments: Procedure: Robotic pancreaticoduodenectomy; Procedure: Open pancreaticoduodenectomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04400357

KY2020-93

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with an indication for elective pancreaticoduodenectomy for malignant, premalignant, and symptomatic benign disease in the pancreatic and periampullary region
• Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score and Malnutrition Universal Screening Tool score among others, especially for patients with malignant disease)
• Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for benign 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 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 pancreatic adenocarcinoma)
• Involvement of major regional vessels by the tumor (portal and superior mesenteric vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the borderline resectable and locally advanced nomenclature

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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268 participants in 2 patient groups

Robotic pancreaticoduodenectomy

Experimental group

Description:

Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy.

Treatment:

Procedure: Robotic pancreaticoduodenectomy

Open pancreaticoduodenectomy

Active Comparator group

Description:

Patients randomized in this arm will undergo a routine open pancreaticoduodenectomy.

Treatment:

Procedure: Open pancreaticoduodenectomy