SLND Versus Non-Dissection Following ESD for T1a Stage Esophageal Squamous Cell Carcinoma

Официальное название

Systematically Mediastinal Lymph Node Dissection (SLND) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma

Обзор

This is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial.

Подробное описание

Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS).

The sample size are estimated with reference to investigators' previous data, in which the 3-year DFS was 62.7% for patients diagnosed with T1a Stage Esophageal Squamous Cell Carcinoma and underwent Endoscopic Submucosal Dissection without SLND. Investigators assumed that if 3-year DFS of patients in SLND group was over 80%, then investigatorswould deem the SLND group to be superior to the non-SLND group. The sample size are estimated to be 102. Therefore, the total number of patients enrolled are designed to be 102.

Вмешательства

• Процедура Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection
  Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the SLND group will receive Endoscopic Submucosal Dissection with systematically mediastinal lymph node dissection
• Процедура Endoscopic Submucosal Dissection without SLND
  Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepare random tables. Participants in the non-SLND group will just receive Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection.

Первичные конечные точки

• DFS [Срок оценки: From enrollment to the end of treatment at 3 years]

Критерии участия

Критерии включения

• Clinical stage T1aN0M0.
• A lesion detected on Endoscopic Ultrasound featured as T1a stage.
• Age 18 to 75.
• Patients who have signed the informed consent form.

Критерии исключения

• • Other than invasive adenocarcinoma by pathological analysis.

• Not complete resected or curative intent.
• Patients who have history of other malignant tumors.
• Patients who have history of thoracic surgery.
• Patients who have received radiation, chemotherapy or other treatments previously.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Nishihira T, Hirayama K, Mori S. A prospective randomized trial of extended cervical and superior mediastinal lymphadenectomy for carcinoma of the thoracic esophagus. Am J Surg. 1998 Jan;175(1):47-51. doi: 10.1016/s0002-9610(97)00227-4. PMID 9445239
• Altorki N, Kent M, Ferrara C, Port J. Three-field lymph node dissection for squamous cell and adenocarcinoma of the esophagus. Ann Surg. 2002 Aug;236(2):177-83. doi: 10.1097/00000658-200208000-00005. PMID 12170022
• Tong DK, Law S, Kwong DL, Chan KW, Lam AK, Wong KH. Histological regression of squamous esophageal carcinoma assessed by percentage of residual viable cells after neoadjuvant chemoradiation is an important prognostic factor. Ann Surg Oncol. 2010 Aug;17(8):2184-92. doi: 10.1245/s10434-010-0995-2. Epub 2010 Mar 9. PMID 20217248
• Tachibana M, Kinugasa S, Yoshimura H, Dhar DK, Nagasue N. Extended esophagectomy with 3-field lymph node dissection for esophageal cancer. Arch Surg. 2003 Dec;138(12):1383-9; discussion 1390. doi: 10.1001/archsurg.138.12.1383. PMID 14662544
• Ando N, Ozawa S, Kitagawa Y, Shinozawa Y, Kitajima M. Improvement in the results of surgical treatment of advanced squamous esophageal carcinoma during 15 consecutive years. Ann Surg. 2000 Aug;232(2):225-32. doi: 10.1097/00000658-200008000-00013. PMID 10903602
• Hsu PK, Huang CS, Wang BY, Wu YC, Hsu WH. Survival benefits of postoperative chemoradiation for lymph node-positive esophageal squamous cell carcinoma. Ann Thorac Surg. 2014 May;97(5):1734-41. doi: 10.1016/j.athoracsur.2013.12.041. Epub 2014 Mar 6. PMID 24612702
• Hsu PK, Wang BY, Huang CS, Wu YC, Hsu WH. Prognostic factors for post-recurrence survival in esophageal squamous cell carcinoma patients with recurrence after resection. J Gastrointest Surg. 2011 Apr;15(4):558-65. doi: 10.1007/s11605-011-1458-1. Epub 2011 Feb 15. PMID 21327531
• Merkow RP, Bilimoria KY, Keswani RN, Chung J, Sherman KL, Knab LM, Posner MC, Bentrem DJ. Treatment trends, risk of lymph node metastasis, and outcomes for localized esophageal cancer. J Natl Cancer Inst. 2014 Jul 16;106(7):dju133. doi: 10.1093/jnci/dju133. Print 2014 Jul. PMID 25031273

Идентификаторы

NCT: NCT06979986 · FJCHTOSP-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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