CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Minimally invasive esophagectomy (MIE)procedure
Likely dose
Not stated in record
Key inclusion· 8
  • High-grade dysplasia of the esophagus requiring esophagectomy OR esophageal cancer stage T1-T3, N0-N1 requiring esophagectomy
  • Pathological confirmation of cancer or high-grade dysplasia by biopsy
  • CT scan of chest and abdomen within 6 weeks prior to registration
  • Stomach available for conduit
Key exclusion· 5
  • Cancer extending into the stomach more than 20%
  • Prior anti-reflux or gastric operations
  • Prior right thoracotomy
  • Prior major neck operation other than removal of superficial skin lesion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00063986
NCT00063986Phase 2Completed

Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Eastern Cooperative Oncology Group·interventional·Posted Jul 9, 2003·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating Minimally invasive esophagectomy (MIE) for Esophageal Cancer. Completed, enrolled 110 participants across 41 sites.

Detailed Summary

RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2003
Enrollment StartJun 24, 2004
Primary CompletionDec 1, 2010
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 23.0 years ago

Interventions

Minimally invasive esophagectomy (MIE)procedure

Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.