Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Inflammation

Recurrence

Cholangiocarcinoma

Adenocarcinoma

Pancreatic Neoplasms

Pancreatitis

Pancreatitis, Chronic

Endocrine Gland Neoplasms

Cysts

Pancreatic Cyst

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Diseases

Gastrointestinal Diseases

Chronic Disease

Disease Attributes

Endocrine System Diseases

Pancreatic Cancer

Bile Duct Cancer

Chronic Graft Versus Host Disease

Pancreatic Neuroendocrine Tumor

Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy.

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

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

Robotic pancreaticoduodenectomy

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

Open pancreaticoduodenectomy

Jiabin JIN, PhD

Georgios Gemenetzis, MD

jiabin JIN, PhD

Baiyong Shen, PhD

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.

Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors

Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial

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.

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

Comparison of estimated blood loss (in ml)

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

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)

Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm

For assessment of postoperative quality of life (QoL) improvement, patients will be evaluated with the established EuqoQol EQ-5D-5L questionnaire, which is a self-reported assay focusing on five parameters: Pain/discomfort, anxiety/depression, usual activities, self-care, and mobility. Each of the five aforementioned parameters is scored from 0 to 5 (no issue, slight problem, moderate problem, severe problem, unable); patients also score independently their health status on a scale numbered from 0 to 100; 100 means the best health they can imagine, and 0 the worst.

Answered questionnaires will be collected on postoperative days 1, 3, 5, 7, and afterwards every week until day 30. QoL evaluation will terminate at Day 90.

In a sub-cohort of patients with pancreatic adenocarcinoma, the margin resection status (R) will be assessed and compared: R0 is defined as presence of tumor \>1mm from the resection margin, R1 as presence of tumor ≤1mm from the resection margin.

* Number of harvested lymph nodes
* Number of positive lymph nodes (infiltrated by tumor)
* Tumor size, degree of differentiation, perineural and lymphovascular invasion

In a sub-cohort of patients with pancreatic adenocarcinoma, the number of harvested and positive lymph nodes (infiltrated by tumor) will be assessed and compared between the two groups.

Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document disease recurrence, defined as the re-presentation of measurable tumor after resection.

Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document overall survival, defined as the time between date of operation and date of death.

Comparison of cost between the two groups, defined as the combination of intraoperative and postoperative costs, measured in US Dollars.

Enrolled patients in the study will be consented for peripheral blood draws in multiple time-points to assess the amount of circulating tumor DNA (ctDNA) and assess potential differences between the two groups in patients with pancreatic adenocarcinoma. The blood draws will occur: 1. immediately pre-operatively, 2. Postoperative days 2, 7, and 30.

Patients C-reactive protein (CRP, measured in ng/L) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

Patients neutrophil-to-lymphocyte ratio (NLR, defined as the division of absolute neutrophil number to absolute lymphocyte number) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

Patients Interleukin 6 (IL-6, measured in pg/mL) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

Intuitive Surgical

Ruijin Hospital

Attending Surgeon, Pancreatic Disease Center

Neoplasms, Cystic, Mucinous, and Serous

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy.

Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy.

Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy.

Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy.

Laparoscopic pancreaticoduodenectomy

Robotic Distal Pancreatectomy

Laparoscopic Distal Pancreatectomy

Hanyu Zhang, M.D.

Menghua Dai, M.D.

MENGHUA Dai, M.D.

Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Conventionally, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. In the ear of minimally invasive pancreatic surgery, when compared with open surgery, laparoscopic technology or Da Vinci robotic technology can avoid some open procedures limitations.

Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures.

Background: Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. Its heterogeneity is large, which can be benign, borderline, and poor differentiation and even evolve into pancreatic cancer. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Some patients may be accompanied by recurrent pancreatitis, abdominal pain, nausea, vomiting, jaundice, and other gastrointestinal symptoms, usually with the help of abdominal ultrasound and endoscopy, ERCP, CT, nuclear magnetic, or MRCP imaging The examination can diagnose the disease. For PCN patients with large tumors, risk of malignant transformation, and accompanying symptoms that affect the quality of life, surgery is an effective treatment.

Based on the conventional routine treatment, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail.

After more than 20 years of development, minimally invasive pancreatic surgery technology can be divided into two categories: laparoscopic technology and Da Vinci robotic technology. In general, compared with open surgery, minimally invasive pancreatic surgery technology can avoid some open procedures limitations, reduce the loss of intraoperative body fluid and its impact on the internal environment, and avoid excessive disturbance to other abdominal organs. It also helps reduce the pain of patients and shorten the length of hospital stay. Because most PCNs are benign or borderline tumors, such patients are eligible for minimally invasive pancreatic surgery.

Aim and Hypothesis: Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures. We conduct a single-center prospective randomized clinical trial to compare the outcomes of different minimally invasive techniques.

The enrolled candidates will be split into two subgroups(PD group or DP group) based on the location of their neoplasms. Every subgroups will be divided into two parallel groups by the randomization of intervention plan(lap surgery or robotic surgery)

Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

Comparison Between Robotic and Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

The rate of frequency of Clavein-Dindo Grade II-IV complication

patients complain of pain after surgery, 0-10, 10 means the greatest pain

The frequency of grade B or C pancreatic fistula

Quality of life after surgery, greater means higher life satisfaction

The amount of treatment expense and certain procedure expense

The rate of death within 90 days after surgery

For DP groups, the rate of spleen being preserved

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors	NCT04400357	Pancreatic Aden... Pancreatic Cyst... Pancreatic Endo... Chronic Pancrea... Cholangiocarcin... Ampullary Adeno... Duodenal Adenoc...	Robotic pancrea... Open pancreatic...	18 Years -	Ruijin Hospital
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors	NCT04400357	Pancreatic Aden... Pancreatic Cyst... Pancreatic Endo... Chronic Pancrea... Cholangiocarcin... Ampullary Adeno... Duodenal Adenoc...	Robotic pancrea... Open pancreatic...	18 Years -	Ruijin Hospital
Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms	NCT05259384	Pancreatic Neop...	Robotic pancrea... Laparoscopic pa... Robotic Distal ... Laparoscopic Di...	18 Years -	Peking Union Medical College Hospital
Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms	NCT05259384	Pancreatic Neop...	Robotic pancrea... Laparoscopic pa... Robotic Distal ... Laparoscopic Di...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for robotic pancreaticoduodenectomy