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The Comparison of Single and Multi-incision MIE for Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03646110
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE).The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Minimally invasive esophagectomy Not Applicable

Detailed Description:
Surgery remains the main stay of treating esophageal cancer. However, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. The standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. The procedure of MIE including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE). The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer
Actual Study Start Date : August 17, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single-incision MIE
Esophageal cancer patients received single-incision Minimally invasive esophagectomy
Procedure: Minimally invasive esophagectomy
Minimally invasive esophagectomy is a surgical procedure for esophageal resection

Active Comparator: multi-incision MIE
Esophageal cancer patients received multi-incision Minimally invasive esophagectomy
Procedure: Minimally invasive esophagectomy
Minimally invasive esophagectomy is a surgical procedure for esophageal resection




Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: 60 months ]
    Overall survival rate of the participants after surgery


Secondary Outcome Measures :
  1. Pain score as assessed by the face rating scale [ Time Frame: 1,7,14,28 days ]
    The scale range of face rating scale is ranging from 0 (happy face) to 10 (crying face). Higher values represent a worse outcome.

  2. Ratio of ambulation [ Time Frame: post-operative day 2 (POD2) ]
    30-minute walk test

  3. Postoperative force vital capacity [ Time Frame: 1 and 3 months ]
    Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry

  4. Post operative forced expiratory volume in one second [ Time Frame: 1 and 3 months ]
    Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry

  5. Postoperative pulmonary complication [ Time Frame: 1 month ]
    pulmonary complication after esophagectomy



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of esophageal cancer
  2. Age between 35 to 75 years old
  3. Resectable tumor as evaluation by preoperative imaging studies.

Exclusion Criteria:

  1. Previous surgery in the chest or abdomen.
  2. Receiving definitive chemoradiation (5500 cGy or more).
  3. Tumor invasion to the trachea, spine or aorta.
  4. Liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, Child C classification.
  5. Previous history of cerebral vascular attack.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646110


Contacts
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Contact: Jang-Ming Lee, MD PhD +886972651439 ntuhlee@yahoo.com
Contact: Pei-Wen Yang, PhD +88623123456 ext 65123 pwy1210@gmail.com

Locations
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Taiwan
Jang-Ming Lee Recruiting
Taipei City, Zhongzheng Dist., Taiwan, 100
Contact: Jang-Ming Lee, MD PhD    886-972651439    jmlee@ntu.edu.tw   
Contact: Pei-Wen Yang, PhD.    886-2-23123456 ext 65123    pwy1210@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital

Additional Information:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03646110     History of Changes
Other Study ID Numbers: 201804074RINA
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
esophageal cancer
Minimally invasive esophagectomy (MIE)
single-incision Minimally invasive esophagectomy (SIMIE)

Additional relevant MeSH terms:
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Esophageal Neoplasms
Surgical Wound
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Wounds and Injuries