Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.

open gastric mobilization and gastric tube formation

In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.

minimally invasive esophagectomy

in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.

open esophagectomy

The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the minimally invasive approach with the standard open procedure regarding morbidity and mortality.

Esophageal resection is still associated with considerable morbidity and mortality. Standardized preoperative efforts could increase the outcome of these patients. While early reports of medical pioneers focused particularly on safety and feasibility, more recent studies showed that implementation of minimally invasive esophagectomy (MIE) was widely accepted. Since first reports of MIE, different techniques and adjustments have been discussed. A recent publication of a large prospective trial in Phase II showed the safety of a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and laparoscopy). Surgical technique however is still a subject of debate and the level of evidence remains still low. Proving feasibility does not warrant a paradigm shift, as experience is an important factor for safety and patient benefit.

The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE) versus hybrid-MIE in a randomized controlled setting.

Prior to surgery patients will be randomized either the minimally invasive surgery group (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open gastric tube formation with an open laparotomy approach). Randomizing tool is the "randomizer" of the medical university of vienna. (link is attached below)

Morbidity in Open Versus Minimally Invasive Esophagectomy

Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy

anastomotic leakage, gastric conduit necrosis and/or pneumonia

length of stay at the intensive care unit (ICU)

Austrian Society Of Surgical Oncology

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Thrombosis

Pulmonary Embolism

Embolism

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Embolism and Thrombosis

Vascular Diseases

Yaron Shargall

The purpose of this study is to determine the incidence of post-operative venous thromboembolism (VTE) in patients undergoing major esophageal resection for malignancy.

Venous Thromboembolism (VTE) is a common post-operative complication that can result in significant patient morbidity, mortality and health care resource utilization to treat the resultant Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) events. It is the third leading cause of cardiovascular mortality. Due to the high burden of disease, VTE events are actively prevented using mechanical and/or pharmaceutical prophylaxis interventions such as compression stockings or a variety of anti-coagulants. Extensive literature identifies incidence rates and provides guidelines regarding the use of prophylaxis measures in orthopaedic and oncological surgery, but the literature in thoracic surgery is sparse at best or conflicting with reported incidence of symptomatic events ranging from 5% to 14% after esophagectomy. The current practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin (LMWH) starting in the perioperative period and finishing at patient discharge, while prolonged thromboprophylaxis in orthopaedic surgery beyond 10 to 14 days and up to 35 days has become the standard of care. Such an approach has never been tested or validated in esophageal cancer patients despite the substantial burden and high risk of VTE events in this population. There is a clear need for well-designed studies aiming to define the extent of peri-operative VTE for esophagectomy patients and additional contributing factors associated with VTE in those high risk patients in order to inform best practice patterns. The investigators hypothesize that the incidence and clinical burden of perioperative VTE events in esophagectomy patients are substantial, and that VTE significantly contributes to peri-and post-operative morbidity and mortality. Hence, it will be beneficial to explore the true incidence of VTE events and evaluate the effectiveness of extended-duration, post-discharge prophylaxis for these patients. The investigators also hypothesize that sub-groups of esophagectomy patients will be at higher risk for VTE events and therefore might benefit more from extended-duration, post-discharge prophylaxis, and perhaps from a more aggressive in-hospital regimen.

This prospective cohort study will involve patients undergoing major esophageal resection for esophageal cancer at 9 tertiary care centres across Canada, 4 centres in the USA, and 1 site in China. McMaster University at St. Joseph's Healthcare Hamilton will serve as the Coordinating Centre as well as a study site. Recruitment will commence at each site until 177 patients are enrolled via consecutive convenience sampling. After undergoing esophagectomy, all patients will receive both a peri-operative dose followed by post-operative LMWH VTE prophylaxis for the remainder of their hospital stay. As per current VTE prophylaxis guidelines, prophylaxis will be discontinued upon hospital discharge. VTE outcomes will be assessed using Computed Tomography with pulmonary angiography protocol at 30 and 90 days and bilateral venous Doppler ultrasounds at 30, 60 and 90 days after surgery. The role of D-Dimer will be investigated peri-operatively up to post-operative day (POD) 3, at hospital discharge or POD 10 (whichever is applicable), and at each imaging follow-up visit. A future second phase study will be a randomized controlled trial that will evaluate the role of extended duration thromboprophylaxis post-discharge in reducing the incidence of VTE in this patient population. The proposed prospective cohort study to evaluate the incidence of VTE needs to be conducted first, in order to optimize patient selection and determine the sample size for the subsequent randomized controlled trial.

Incidence of Venous Thromboembolism in Patients Undergoing Major Esophageal Resection

The Contemporary Significance of Deep Venous Thrombosis and Pulmonary Embolus in Patients Undergoing Esophagectomy: A Pilot Study to Evaluate the Incidence of DVT and PE After Major Esophageal Resections

CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT

Multiple measurements aggregated to arrive at one reported value (e.g., number of participants with adverse events that are related to DVT and PE).

Multiple measurements used including patient characteristics, surgical details, physiological parameters, and patient-reported symptoms questionnaire.

Blood samples used to assess D-Dimer levels to investigate the role of this laboratory test as a quantifiable clinical measure of VTE risk.

McMaster University

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.

Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.

6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy

OncoGel (Paclitaxel gel)

75 mg/m2 IV (in the vein) once on Day 1 and Day 29

cisplatin

1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29

5-FU

50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks

radiation therapy

Removal of esophagus after completion of chemotherapy and radiation therapy

esophageal resection

Kirk D Fowers, PhD

OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.

The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and 5-FU) and radiation therapy before surgery.

The primary objective of this study is to evaluate the efficacy of OncoGel given in combination with standard chemotherapy (cisplatin and 5-FU) and radiation therapy in patients with previously untreated, resectable, local or local-regional adenosarcoma or squamous cell carcinoma.

All patients will receive IV cisplatin on Day 1 and Day 29 and IV 5-FU given continuously for 96 hours starting on Day 1 and Day 29. All patients will also receive out-patient radiation therapy for 28 treatments once per day for 5 1/2 weeks starting on Day 1.

Patients randomized to the OncoGel treatment group will have the OncoGel dose injected into their esophageal tumors during an endoscopic procedure just before starting systemic chemotherapy and radiation therapy.

All patients will have CT scans for tumor measurements before starting chemotherapy and 12 weeks later after completion of the radiation therapy and both cycles of chemotherapy.

During the chemotherapy and radiation therapy, physical exams, vital signs, routine blood tests will be performed. Patients will also be asked about their quality of life and ability to swallow.

In-patient surgery will be scheduled 4 to 6 weeks after completion of chemotherapy and radiation therapy. The resected esophagus and lymph nodes will be evaluated for the presence of residual tumor.

Patients will be followed at months 4, 5, 6, and then every 3 Months thereafter for survival and esophageal cancer status and treatment until the last patient enrolled has completed their Month 12 visit.

Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer

A Randomized Study of the Efficacy and Safety of OncoGel™ Treatment as an Adjunctive Therapy to Systemic Chemotherapy and Concurrent External Beam Radiation Prior to Surgery in Subjects With Localized or Loco-regional Esophageal Cancer

Per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and by Spiral CT assessment:

Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Boston Scientific Corporation

Serious adverse events were collected through the first 30 days after the Week 12 visit

Group 1

Group 2

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Czech Republic

Poland

Belgium

India

Region of Enrollment

Study prematurely terminated due to lack of efficacy in primary endpoint.

Jessie Stockwell

Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy.

Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT

Overall Study

Symptoms and General Pathology

Anastomotic Leak

Postoperative Complications

A prospective, blinded, intraindividual controlled study is conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study is performed prior to endoscopy at the 5th to 7th postoperative day.

Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines

Contrast swallow radiography, endoscopy

Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Morbidity in Open Versus Minimally Invasive Esophagectomy	NCT03035071	Esophageal Canc...	minimally invas... open esophagect...	18 Years - 80 Years	Austrian Society Of Surgical Oncology
Incidence of Venous Thromboembolism in Patients Undergoing Major Esophageal Resection	NCT03115541	Venous Thromboe... Thoracic Surger... Esophageal Canc...		18 Years -	McMaster University
Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer	NCT00573131	Esophageal Canc... Adenocarcinoma ... Squamous Cell C...	OncoGel (Paclit... cisplatin 5-FU radiation thera... esophageal rese...	18 Years -	Boston Scientific Corporation
Incidence of Venous Thromboembolism in Patients Undergoing Major Esophageal Resection	NCT03115541	Venous Thromboe... Thoracic Surger... Esophageal Canc...		18 Years -	McMaster University
Detection of Anastomotic Leakage After Esophageal Surgery	NCT00642525	Esophageal Canc... Anastomotic Lea...	Contrast swallo...	18 Years -	Heidelberg University
Detection of Anastomotic Leakage After Esophageal Surgery	NCT00642525	Esophageal Canc... Anastomotic Lea...	Contrast swallo...	18 Years -	Heidelberg University

Spots Global Cancer Trial Database for esophageal resection