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A clinical trial comparing pulmonary complications in two routes of gastric conduit placement after esophagectomy

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062245
Enrollment
30
Registered
2024-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C158- Malignant neoplasm of overlappingsites of esophagus

Interventions

Intervention1: Surgical: Retrosternal gastric route Intervention2: Surgical: gastric conduit for esophagogastric anastomosis is taken through retrosternal route( intervention arm) for a duration of 6

Sponsors

AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria: 1. Locally advanced esophageal cancer deemed unresectable as per MDT discussion 2. Metastatic/Recurrent esophageal cancer 3. Increased pulmonary risk (FEV1 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. To assess the impact of retrosternal and posterior mediastinal gastric conduit placement on postoperative pulmonary function. 2. To investigate the association between route of gastric conduit placement, duration of surgery and length of hospital stay 3. To assess the impact of retrosternal and posterior mediastinal gastric conduit placement on postoperative anastomotic leak rates Timepoint: 2 years

Countries

India

Contacts

Public ContactAmit kumar

AIIMS NEW DELHI

drsandeepbhoriwal@gmail.com9811104423

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026