Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
3 septembre 2018 mis à jour par: Qingdong Cao
A Multi-center Clinical Study on the Feasibility and Safety of Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
This study is evaluating the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
This is a prospective, multicenter, open clinical study in which 155 patients (including 5% shedding rate) who require surgical treatment are scheduled to be included in the study.
Prior to any screening process, each subject / legal guardian should sign the informed consent form.
Screening tests are used to determine whether each subject is eligible for the study.
Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 3 years postoperatively.
Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
Type d'étude
Interventionnel
Inscription (Anticipé)
155
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine
- Pas encore de recrutement
- Beijing Chao-Yang Hospital
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Contact:
- Li Hui, doctor
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Chongqing
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Chongqing, Chongqing, Chine
- Pas encore de recrutement
- Affiliated Daping Hospital
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Contact:
- Tan Qunyou, doctor
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Fujian
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Xiamen, Fujian, Chine
- Pas encore de recrutement
- The First Affiliated hospital of Xiamen University
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Contact:
- Yu Xiuyi, doctor
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Guangdong
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Guangzhou, Guangdong, Chine
- Pas encore de recrutement
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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Contact:
- Chen Ju, doctor
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Shantou, Guangdong, Chine
- Pas encore de recrutement
- Shantou Central Hospital
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Contact:
- Fu Junhui, doctor
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Guizhou
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Zunyi, Guizhou, Chine
- Recrutement
- Affiliated Hospital of Zunyi Medical College
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Contact:
- Cai Qingyong, master
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Hainan
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Haikou, Hainan, Chine
- Pas encore de recrutement
- The Second Affiliated Hospital of Hainan Medical University
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Contact:
- Wu Huangfu
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Heilongjiang
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Harbin, Heilongjiang, Chine
- Pas encore de recrutement
- Harbin Medical University Cancer Hospital
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Contact:
- Ma Jianqun, doctor
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Henan
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Anyang, Henan, Chine
- Recrutement
- Anyang Cancer Hospital
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Contact:
- Hou Jianbin, doctor
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Hubei
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Xiangyang, Hubei, Chine
- Recrutement
- Xiangyang No.1 People's Hospital
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Contact:
- Mei Yunqing, doctor
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Jiangsu
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Changzhou, Jiangsu, Chine
- Pas encore de recrutement
- The First People's Hospital of Changzhou
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Contact:
- Wang Zhonglin
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Nanjing, Jiangsu, Chine
- Recrutement
- Jiansu Cancer Hospital
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Contact:
- Hu Zhendong, doctor
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Shandong
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Jining, Shandong, Chine
- Recrutement
- Jining No.1 people's Hospital
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Contact:
- Zhang Kang
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Shanghai
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Shanghai, Shanghai, Chine
- Recrutement
- Shanghai Chest Hospital
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Contact:
- Sun Yifeng, doctor
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Shanghai, Shanghai, Chine
- Pas encore de recrutement
- Shanghai Changzheng Hospital
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Contact:
- XU Zhifei, doctor
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Shanxi
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Xi'an, Shanxi, Chine
- Recrutement
- The First Affiliated Hospital of Xi'an Jiaotong University
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Contact:
- Fu Junke, doctor
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The Ningxia Hui Autonomous Region
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Yinchuan, The Ningxia Hui Autonomous Region, Chine
- Recrutement
- General Hospital of Ningxia Medical University
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Contact:
- He Wei, master
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Xinjiang
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Ürümqi, Xinjiang, Chine
- Pas encore de recrutement
- Affiliated Tumor Hospital of Xinjiang Medical University
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Contact:
- Sun Wei, doctor
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Yunnan
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Kunming, Yunnan, Chine
- Pas encore de recrutement
- The First People's Hospital of Yunnan Province
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Contact:
- Pu Liang, doctor
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Zhejiang
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Hangzhou, Zhejiang, Chine
- Pas encore de recrutement
- Zhejiang Cancer Hospital
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Contact:
- Liu Jinshi
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Ningbo, Zhejiang, Chine
- Pas encore de recrutement
- Ningbo No.2 Hospital
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Contact:
- Zhao Guofang
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Aged 18-85 years male and female
- Patients with esophageal squamous cell carcinoma diagnosed by cytological or histological examination, requires surgical treatment
- Patients in tumor stage of T1-2N0-1M0 confirmed by ultrasonic gastroscopy preoperatively;Or patients in T3N1M0 (IIIa) reached PR after neoadjuvant radio(chemo-) therapy, suitable for surgical resection
- The tumor located in the chest or abdomen segment of esophagus
- No surrounding vital organs were invaded and no distant metastasis
- No obvious enlargement was shown in supraclavicular and retroperitoneal lymph nodes, no evidence of distant metastasis (M0)
- Vital organs function normally: lung functions normally and could stand general anesthesia; NYHA heart function grade 0 ~ 1
- Informed consent was signed as voluntarily before study, and patients and/or the legal representatives have the ability to fully understand test content/result, process and possible adverse reactions, and patients could comply with the requirements of the follow-up scheme
- Reproductive women must show a negative pregnancy test, and it should be confirmed that both the women patient and her spouse are taking contraceptives recognized by researchers, and should keep taking this contraceptive by signing the informed consent until 3 months after the study was finished.
Exclusion Criteria:
- Patients with other malignant tumors at the same time
- Patients having surgery history of esophageal or gastric resection
- Patients having a history of mediastinal surgery or vast peritoneal adhesion
- Patients with heart thromboembolism at the same time
- People with psychological, mental or nervous system diseases
- Cachexia, severe malnutrition patients
- Patients with history of recent recurrence of gastric ulcer, stomach bleeding and other severe basic diseases
- Patients with blood coagulation dysfunction, HIV antibody positive, or surgical contraindications such as clinically poorly controlled serious infection
- The subjects with other associated disease (such as liver and renal dysplasia, etc.) or drug combination, which could influence the study results recognized by the researchers
- Patients participating in another clinical study
- Patients with surgical instruments material allergy, or allergic constitution
- The subjects are not judged by investigator to participate in this Clinical trial.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Inflatable mediastinal mirror
Patients with especially esophageal squamous cell carcinoma ( ESCC ) who meet the inclusion criteria and do not meet the exclusion criteria will undergo radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, and will be followed up until 3 years after discharging from the hospital.
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The radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma is new minimally invasive operation for esophageal carcinoma.
All enrolled subjects will receive this operation for their ESCC.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perioperative complication rate
Délai: Through operation completion, an average of 12 days
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Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
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Through operation completion, an average of 12 days
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Number of lymph nodes dissected
Délai: During the operation
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number of lymph nodes dissected during operation
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During the operation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intraoperative bleeding volume
Délai: During the operation
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Calculation of intraoperative bleeding with ml/kg
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During the operation
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Operative time
Délai: During the operation
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Calculate the operating time in minutes
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During the operation
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Proportion of patients undergoing thoracotomy or laparotomy
Délai: During the operation
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The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery
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During the operation
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Intraoperative mortality
Délai: During the operation
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The ratio of the number of patients who died during the operation to the number of patients who underwent the operation
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During the operation
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Postoperative hospital stay
Délai: Up to 2 weeks after the operation
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The days of postoperative hospitalization
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Up to 2 weeks after the operation
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Postoperative pain score
Délai: 1-3 days after the operation
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Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation
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1-3 days after the operation
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Postoperative icu monitoring time
Délai: 0-12 days after the operation
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If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed
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0-12 days after the operation
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Incidence of adverse events during and after operation
Délai: 3 years
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Special attention is paid to observing whether arrhythmias need to be dealt with during the operation (record the types of arrhythmias, treatment methods, medication, time of occurrence, possible causes)
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3 years
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Postoperative drainage
Délai: 0-12 days after the operation
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Total postoperative thoracic or mediastinal drainage (ml/kg)
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0-12 days after the operation
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Postoperative drainage tube indwelling time
Délai: 0-12 days after the operation
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The retention time of different types of drainage tube
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0-12 days after the operation
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Local recurrence rate of tumor within 3 years
Délai: 3 years
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The rate of tumor recurrence or metastasis
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3 years
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Liu Shaoxuan, master, Office of clinical research center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 juillet 2017
Achèvement primaire (Anticipé)
1 mars 2019
Achèvement de l'étude (Anticipé)
1 mars 2019
Dates d'inscription aux études
Première soumission
6 août 2018
Première soumission répondant aux critères de contrôle qualité
3 septembre 2018
Première publication (Réel)
5 septembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 septembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 septembre 2018
Dernière vérification
1 septembre 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZDWY.XXW.001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .