NCT05945654

Brief Summary

The main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to Ivor Lewis. However, despite careful work and refined surgical techniques, anastomotic leakage (AL) occurs in more than 1/10 of the patients. This severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (EVT) has become the crucial therapy for broken-down anastomosis. The hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by EVT after an anastomotic leak, compared to patients without AL.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

June 6, 2023

Last Update Submit

April 22, 2026

Conditions

Anastomotic Leak EsophagusSwallowing Disorder

Outcome Measures

Primary Outcomes (3)

  • Swallow function by questionnaires: Sydney Swallow Questionnaire (SSQ)

    This questionnaire consists of 17 questions and is mainly based on a visual analog scale (VAS) to assess functional swallowing. The sum of all questions ranges from 0-1700. The calculated upper limit of the reference interval is 234 in a non-dysphagic population. A higher score represents a more severe dysphagia.

    earliest 6 months postoperatively

  • Swallow function by questionnaires: Eckardt Score (ES)

    The ES is a questionnaire with four items (weight loss, chest pain, regurgitation, and dysphagia) initially used to evaluate achalasia. The maximum score is 12; the higher the score, the more trouble patients have with swallowing.

    earliest 6 months postoperatively

  • Swallow function by questionnaires: Brief Esophageal Dysphagia Questionnaire (BEDQ)

    The BEDQ has 10 questions to score dysphagia specifically. The questions are answered using a Likert scale (low to high), which sums up to a score ranging from 0 (asymptomatic) to 40.

    earliest 6 months postoperatively

Secondary Outcomes (2)

  • Quality of life by questionnaires EORTC-C30 (European Organisation for Research and Treatment of Cancer-Cancer 30)

    earliest 6 months postoperatively

  • Quality of life by questionnaires EORTC-OG25 (Oesophagogastric-25)

    earliest 6 months postoperatively

Study Arms (2)

Anastomotic leak

Patients who had an Ivor Lewis Oesophagectomy and suffered an anastomotic leak (AL) postoperatively. AL, as defined according to ECCG (Esophagectomy Complication Consensus Group) criteria 1-3.

Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy

No anastomotic leak

Patients who had an Ivor Lewis Oesophagectomy and had no AL postoperatively, ECCG 0.

Interventions

Anastomotic Leak after Ivor Lewis OesophagectomyPROCEDURE

Surgical resection of the esophagus with oesophagogastrostomy. Groups depend on postoperative complication

Anastomotic leak

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients, according to the above mentioned criteria who were operated at Stadtspital Triemli between 01.06.2018 and 31.5.2022

You may qualify if:

  • Patients who received an Ivor Lewis Oesophagectomy with reconstruction due to any reason
  • Patients older than 18 years

You may not qualify if:

  • Patients with achalasia
  • inability to understand study procedure or to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stadtspital Zurich, Triemli

Zurich, Canton of Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Stefan Gutknecht, MD

    Stadtspital Zurich

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 14, 2023

Study Start

September 1, 2023

Primary Completion

April 22, 2026

Study Completion

April 22, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)