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There is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes. However, in Western countries patients with cervical lymph node metastases are generally precluded from curative treatment.
Objective: To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases. Secondary objective is to determine the effect on survival and recurrence.
Study design: Mono centre prospective phase II single-arm feasibility study. Study population: Western patients diagnosed with resectable (cT1-4a, N1-3) intra thoracic esophageal carcinoma with histological or cytological proven cervical lymph node metastases in level III and/ or IV.
Intervention: Transthoracic esophageal resection combined with three field lymphadenectomy after neoadjuvant chemo-radiation.
Main study parameters/ endpoints: Primary outcome is the percentage of overall surgical complications grade 3b and higher as stated by the Modified Clavien-Dindo classification. Secondary outcomes are mortality, operation related events and postoperative recovery, including quality of life, disease free survival, overall survival and if applicable the location of recurrent disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery | Other | esophagectomy with three-field lymphnode dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esophagectomy with three-field lymphnode dissection | Procedure | robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC) | Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages) | 5 years |
| survival | 5 year overall- and disease free survival. |
| Measure | Description | Time Frame |
|---|---|---|
| pathology results 1 | pTNM stage | 5 years |
| pathology results 2 | site of tumour | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard V Hillegersberg, Prof Dr | UMCU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36707482 | Derived | van der Horst S, Weijs TJ, Braunius WW, Mook S, Mohammed NH, Brosens L, van Rossum PSN, Weusten BLAM, Ruurda JP, van Hillegersberg R. Safety and Feasibility of Robot-Assisted Minimally Invasive Esophagectomy (RAMIE) with Three-Field Lymphadenectomy and Neoadjuvant Chemoradiotherapy in Patients with Resectable Esophageal Cancer and Cervical Lymph Node Metastasis. Ann Surg Oncol. 2023 May;30(5):2743-2752. doi: 10.1245/s10434-022-12996-x. Epub 2023 Jan 27. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 5 years |
| quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18) | QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18) | 10 years |
| operation related events 1 | duration of surgery (minutes) | 5 years |
| operation related events 2 | reason for prolongation of surgery if applicable | 5 years |
| operation related events 3 | unexpected events/ complications | 5 years |
| operation related events 4 | bloodloss (ml) reason for conversion if applicable. | 5 years |
| operation related events 5 | reason for conversion if applicable. | 5 years |
| postoperative recovery | duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days), | 5 years |
| pathology results 3 | length of tumour | 5 years |
| pathology results 4 | type of tumour | 5 years |
| pathology results 5 | gradation of tumour | 5 years |
| pathology results 6 | margins of resection (R0, R1, R2) | 5 years |
| pathology results 7 | mandard score | 5 years |
| pathology results 8 | lymphnode status | 5 years |
| pathology results 9 | vaso-invasion | 5 years |
| pathology results 10 | perineural growth | 5 years |