Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Esophageal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Cancer

Patients undergoing esophagectomy with ActivSight (n=70)

Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy.

ActivSight

Peter Kim, MD

Chris McCulloh, MD

Julie Ward, RN, BSN

Inderpal S Sarkaria, MD

James D Luketich, MD

Meredith Schwarz, RN, MSN

Blair A Jobe, MD

Kirsten Newhams, MD, MPH

ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively.

Primary Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. The investigators will compare the precision and accuracy among the naked eye inspection, ICG and LSCI in assessing the vascularity of the conduit.

Design:

* This is a prospective interventional cross-over study where ActivSight™ will be used in sequence to the standard practice of visualizing perfusion status of the conduit using the naked eye visual inspection and ICG during esophageal resection.
* Feasibility will be determined by technically successful completion of intended visualization.
* Safety will be determined through clinical assessments and evaluation of any adverse event.
* Assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to ICG-based visualization and usability.
* Patient outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
* Target enrollment for the assessment of esophageal anastomoses is a total of seventy patients powered to detect \~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized sites in the gastric conduit. Since ActivSight™ can detect the difference of \> 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p\<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators will recruit a total of 70 patients for the proposed study.

Target enrollment for the assessment of esophageal anastomoses is a total of 70 patients powered to detect \~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized site in the gastric conduit. Since ActivSight™ can detect the difference of \> 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p\<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators recruit a total of 70 patients for the proposed study.

Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans

To determine safety of ActivSight™ in patients undergoing esophageal surgery, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSight™ will be deemed safe if no hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered.

Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test.

Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How easy was ActivSight to set up?

Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?

Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?

Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: "Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?"

Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to use while operating."

Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to set up for the procedure."

Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree):

Yes/No if surgeons changed intraoperative planning/decisions based on ActivSight™, with additional details (what did they change and why) requested if yes.

ActivSightTM ability to display perfusion at a tissue level during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display tissue perfusion of the anatomy during anastomoses in comparison to ICG?"

ActivSightTM ability to display blood vessels during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display vascularity of the anatomy during anastomoses in comparison to ICG?"

University of Pittsburgh Medical Center

West Penn Allegheny Health System

Activ Surgical

Stomach 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

Robot Assisted Distal Gastrectomy

Age, Categorical

Age, Continuous

Sex: Female, Male

Japan

Region of Enrollment

Doctor Masanori Tokunaga

The Incidence of Post-operative Intra-abdominal Infectious Complications

Overall Survival

Relapse Free Survival

Completion Rate of Robot Assisted Surgery

Incidence of Adverse Events

Overall Study

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

A surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity.

A minimally-invasive technique in which operations are performed via small incisions (usually 0.5-1.5 cm) at a location distant to the site of interest.

A minimally-invasive approach that allows good precision, flexibility, and control.

Where the protectomy is performed down to up until the Douglas pouch

Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME

TME with LAR

Philippe ROUANET, MD

Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicenter trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery, or transanal surgery in high-surgical-risk patients with mid-to-low, non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in a technique. Oncologic, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥1 mm, TME grade III, and minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Secondary endpoints will include the co-primary endpoints over the long-term (2 years), quality of surgery, quality of life, length of hospital stay, operative time, and rate of unplanned conversions.

Rectal Surgery Evaluation Trial (RESET)

Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer

CRM, TME grade III, The absence of clavien dindo grade III-IV complications within 30 days post op

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans	NCT05591053	Esophagus Cance... Esophageal Canc... Esophageal Neop... Esophageal Dise... Esophageal Aden... Esophageal Squa... Esophagus SCC Esophagus Tumor Esophagus Adeno... Esophagus Neopl...	ActivSight	18 Years -	Activ Surgical
Phase II Study for Robot Assisted Distal Gastrectomy	NCT01504997	Early Gastric C...	Robot assisted ...	20 Years - 80 Years	Shizuoka Cancer Center
Rectal Surgery Evaluation Trial (RESET)	NCT03574493	Rectal Cancer	TME with LAR	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

Spots Global Cancer Trial Database for robot assisted surgery