A clinical trial comparing pulmonary complications in two routes of gastric conduit placement after esophagectomy
Phase 2
- Conditions
- Health Condition 1: C158- Malignant neoplasm of overlappingsites of esophagus
- Registration Number
- CTRI/2024/02/062245
- Lead Sponsor
- AIIMS NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pulmonary complications in post operative period between patients undergoing retrosternal gastric conduit placement vs posterior mediastinal gastric conduit placement.Timepoint: 2 years
- Secondary Outcome Measures
Name Time Method 1.To assess the impact of retrosternal and posterior mediastinal gastric conduit placement on postoperative pulmonary function. <br/ ><br>2.To investigate the association between route of gastric conduit placement, duration of surgery and length of hospital stay <br/ ><br>3.To assess the impact of retrosternal and posterior mediastinal gastric conduit placement on postoperative anastomotic leak rates <br/ ><br>Timepoint: 2 years