Observation study on the distribution of esophageal cancers in lymph node
- Conditions
- Health Condition 1: K22- Other diseases of esophagus
- Registration Number
- CTRI/2019/10/021526
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Primary squamous cell or adenocarcinoma of the esophagus or esophagogastric junction
2. Surgically resectable (cT1-4a, N0-3, M0)
3. Adequate physical condition to undergo transthoracic surgery (ASA 1-3)
4. Transthoracic esophagectomy
5. 18 Years and above
1. A potential subject who meets any of the following criteria will be excluded from participation in this study:
2. Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach
3. Patients with in situ carcinoma or high-grade dysplasia.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The distribution of lymph node metastases in esophageal and esophago-gastric junction carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and (disease free) survival.Timepoint: Demographic <br/ ><br>Pre Operative <br/ ><br>Per Operative <br/ ><br>Post Operative
- Secondary Outcome Measures
Name Time Method Accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS to existing staging with EUS/PET-CT <br/ ><br>Analysis of the phenomenon skip nodal metastases <br/ ><br>Ratio of nodal metastases inside and outside the radiation field <br/ ><br>Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy <br/ ><br>In-field- or out-field nodal recurrence in case of neo-adjuvant chemoradiation <br/ ><br>Timepoint: 3- and 5-year overall and disease free survival