Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors

Ruijin Hospital268 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

268

Conditions

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

Interventions

Robotic pancreaticoduodenectomyPROCEDURE

Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.

Open pancreaticoduodenectomyPROCEDURE

Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Time to functional recovery postoperatively

Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following: * Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score) * Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired) * Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support * No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.

Time frame: From date of surgery to date of functional recovery as described, assessed up to 90 days.

Secondary Outcomes

Intraoperative blood loss

Comparison of estimated blood loss (in ml)

Time frame: During surgery

Operative time

Comparison of operative time (in minutes, from first incision to skin closure)

Time frame: During surgery

Percentage of patients with pancreatic adenocarcinoma who achieve administration of adjuvant chemotherapy at 8 weeks postoperatively

The number of patients who are fit and well to initiate adjuvant chemotherapy at the 8-week mark after the operation will be documented and compared between the two arms

Time frame: Postoperative Day 1 to Day 56

Postoperative complication rates and associated interventions

Comparison of post-pancreatectomy morbidity between the two surgical approaches, that focus on: * Pancreatic fistula * Bile leak * Chyle leak * Delayed gastric emptying * Surgical site infection * Postoperative pancreatitis * Postoperative hemorrhage * Surgical site infections * Other complications Additional documentation of re-intervention (radiological, endoscopic, or surgical) and re-admission rates, as well as postoperative hospital and ICU length of stay (time to discharge)

Data from ClinicalTrials.gov

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