Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

minimally invasive esophagectomy (MIE) with cervical anastomosis

MIE Ivor- Lewis

MIE McKeown

Yunpeng Zhao

Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:

MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.

A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

The Second Hospital of Shandong University

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Pain, Postoperative

Lung Neoplasms

Pain

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antipyretics

Analgesics

All Drugs and Chemicals

Pharmaceutical Solutions

Central Nervous System Depressants

Acetaminophen

Opiate Alkaloids

Analgesics, Non-Narcotic

Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.

Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.

1000mg IV Ofirmev given every six hours for a total of four doses.

IV Acetaminophen

Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.

Saline Placebo

Hugh Hemmings, MD, PhD

We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.

We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. One group of subjects will receive IV acetaminophen every six hours beginning within 30 minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the other group will receive IV placebo every six hours plus IV morphine PCA, a standard treatment for postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.

Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

A Double-blind, Randomized, Placebo-controlled Study to Compare the Effectiveness of IV Acetaminophen Administered Intra-operatively in Reducing the Use of Opiates to Treat Post-operative Pain

How much morphine the subject consumes in the first 24 hours after surgery (mg).

The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation

2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

Mallinckrodt

Weill Medical College of Cornell University

Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.

Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.

Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.

IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy	NCT04217239	Esophageal Canc...	MIE Ivor- Lewis MIE McKeown	30 Years - 80 Years	The Second Hospital of Shandong University
Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery	NCT01783236	Lung Tumor	IV Acetaminophe... Saline Placebo	18 Years - 99 Years	Weill Medical College of Cornell University
Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery	NCT01783236	Lung Tumor	IV Acetaminophe... Saline Placebo	18 Years - 99 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for thoracoscopic