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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

robot-assisted laparoscopic prostatectomy

conventional laparoscopic radical prostatectomy

Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy

Prostatectomy

Jens-Uwe Stolzenburg, Prof.

This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP).

Purpose: The LAP-01 trial compares outcomes between RARP and LRP.

LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial comparing robotic-assisted and conventional laparoscopic radical prostatectomy.

The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.

The primary outcome is the assessment of time to continence restoration at 3 months. This is evaluated by an assessment of a pad diary completed daily by each patient from the time of catheter removal until restoration of continence. Secondary endpoints include continence and erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after surgery in addition to oncological outcomes up to 3 years follow-up.

With 782 enrolled patients it is the largest trial carried out till date on this topic.

Patients were blinded with respect to the surgical method until the end of the 3-month evaluation and extraction of the primary study outcome.

Laparoscopic vs Robotic-Assisted Radical Prostatectomy

A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy

The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP

Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection

Health-related quality of life questionnaire (EORTC QLQ-C30). Raw scores are linearly transformed into a 0-100 point scale. High global health status and functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL.

Prostate-specific quality of life questionnaire (EORTC QLQ-PR25). Raw scores are linearly transformed into a 0-100 point scale. High functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL.

The Hospital Anxiety and Depression Scales (HADS-D)

Patient satisfaction is measured on a 5-point scale ranging from highly dissatisfied to highly satisfied. Additionally, patients are asked if they would in hindsight make a decision for or against the surgery and if they would advise a friend to undergo surgery under the same circumstances.

Klinikum Dortmund

University Hospital Heidelberg

Heinrich-Heine University, Duesseldorf

University of Leipzig

Prof.

Blood and Lymph Conditions

Lymphocele

Lymphatic Diseases

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Intuitive Vessel Sealer

Ronney Abaza, MD, FACS

The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. Their use in this study will be to perform tissue transection during PLND such that the intended use is within the FDA-approved domain for this instrument. Investigators intend to identify whether its use for PLND reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during PLND. Because the instrument is new and has been FDA approved for less than one year, there is no published literature regarding its use to date.

Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. Investigators propose a total sample size of 120 patients.

Investigators propose a prospective, randomized, single-blinded study of patients diagnosed with pelvic cancer who are electing to undergo robotic surgery with PLND. The patients in our trial will be pelvic cancer patients at risk for lymphocele after PLND. Given the safe nature of the product and the patient's risk for lymphocele after PLND and subsequent potential morbidity, there is justification to give patients the option for inclusion in the study. Investigators intend to determine whether the rate of lymphocele formation after PLND at the time of robotic pelvic cancer surgery can be reduced by using the robotic Vessel Sealer unilaterally for the lymph node dissection. The side of the pelvis of each patient will be randomly selected by Excel's® random number function "RAND()" to receive the Vessel Sealer dissection. Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control and eliminate patient specific confounding variables such as BMI, and surgeon specific factors such as degree and method of hemostasis utilized by each surgeon. In addition, Dr. Abaza will be the only surgeon performing these procedures, eliminating variation in technique between surgeons.

Prevention of Lymphoceles After Robotic PLND

A Pilot Clinical Trial for the Prevention of Lymphoceles After Robotic Pelvic Lymph Node Dissections for Prostate Malignancies Using the da Vinci® EndoWrist® One™ Vessel Sealer

Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis.

Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2).

OhioHealth

Medical Director Robotic Surgery

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Study Participants

Age, Continuous

Sex: Female, Male

Dr. Ronney Abaza

The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.

Lymphoceles

No Lymphoceles

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side.

EndoWrist 1 Vessel Sealer

The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.

Fenestrated Maryland BiPolar Instrument

Lymphoceles were identified by CT scan at 3 months post surgery.

Incidence of Lymphoceles

Surgical Complications

Overall Study

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

patients who received robot assisted distal gastrectomy

Robot assisted distal gastrectomy (DaVinci)

Masanori Terashima, M.D., Ph.D.

The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.

Phase II Study for Robot Assisted Distal Gastrectomy

A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer

Shizuoka Cancer Center

Head of Gastric Surgery

patients who received robot assisted distal gastrectomy

Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy

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
Laparoscopic vs Robotic-Assisted Radical Prostatectomy	NCT03682146	Prostate Cancer	Prostatectomy	18 Years - 75 Years	University of Leipzig
Prevention of Lymphoceles After Robotic PLND	NCT02035475	Lymphoceles Prostate Cancer	Intuitive Vesse...	18 Years -	OhioHealth
Phase II Study for Robot Assisted Distal Gastrectomy	NCT01504997	Early Gastric C...	Robot assisted ...	20 Years - 80 Years	Shizuoka Cancer Center

Spots Global Cancer Trial Database for davinci

Every month we try and update this database with for davinci cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for davinci

Every month we try and update this database with for davinci cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for davinci cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.