NCT00642525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
Last Updated

March 25, 2008

Status Verified

March 1, 2008

Enrollment Period

1.7 years

First QC Date

March 19, 2008

Last Update Submit

March 19, 2008

Conditions

Esophageal CancerAnastomotic Leakage

Keywords

detection of anastomotic leakageesophageal resectiondiagnostic safety

Outcome Measures

Primary Outcomes (1)

  • Detection of anastomotic leakage

    5-7 days after surgical procedure

Study Arms (1)

A

EXPERIMENTAL

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.

Procedure: Contrast swallow radiography, endoscopy

Interventions

Contrast swallow radiography, endoscopyPROCEDURE

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

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

You may not qualify if:

  • no transthoracic resection
  • no primary anastomosis
  • recurrent disease
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, University of Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Esophageal NeoplasmsAnastomotic Leak

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

March 25, 2008

Record last verified: 2008-03

Locations

DE(1)