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Clinical Trials/CTRI/2024/02/062245
CTRI/2024/02/062245
Not yet recruiting
Phase 2

A Phase II Randomised controlled trial comparing pulmonary complications in retrosternal vs posterior mediastinal gastric conduit placement in patients undergoing Esophagectomy - NI

AIIMS NEW DELHI0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C158- Malignant neoplasm of overlappingsites of esophagus

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: C158- Malignant neoplasm of overlappingsites of esophagus
Sponsor
AIIMS NEW DELHI
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
AIIMS NEW DELHI

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients with resectable carcinoma esophagus planned for transthoracic esophagectomy after neoadjuvant treatment (NACT/NACTRT)
  • •2\.ECOG (Eastern cooperative oncology group) performance status 0 and 1

Exclusion Criteria

  • •1\.Locally advanced esophageal cancer deemed unresectable as per MDT discussion
  • •2\.Metastatic/Recurrent esophageal cancer
  • •3\.Increased pulmonary risk (FEV1 \<70 percent predicted, FVC \<70 percent predicted, FEV1/FVC ratio \<0\.65\)
  • •4\.Increased cardiac risk (status post myocardial infarction, grade IV NYHA)
  • •5\.Intrathoracic anastomosis, and reconstruction with other conduits such as colon and jejunum.
  • •6\.History of treatment for previous malignancy.
  • •7\.Pregnant or lactating women.
  • •8\.Patient refused for consent for the study.

Outcomes

Primary Outcomes

Not specified

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