The Comparison of Single and Multi-incision MIE for Esoph... | NCT03646110

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

NCT03646110

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 5, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Esophageal Cancer

Interventions

Minimally invasive esophagectomy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2018Actual

Primary Completion Date

Jul 26, 2021Estimated

Completion Date

Jul 26, 2021Estimated

First Submitted Date

Aug 20, 2018

First Submission Date that Met QC Criteria

Aug 22, 2018

First Posted Date

Aug 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2020

Last Update Posted Date

Nov 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single-incision MIE	Experimental	Esophageal cancer patients received single-incision Minimally invasive esophagectomy	Procedure: Minimally invasive esophagectomy
multi-incision MIE	Active Comparator	Esophageal cancer patients received multi-incision Minimally invasive esophagectomy	Procedure: Minimally invasive esophagectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minimally invasive esophagectomy	Procedure	Minimally invasive esophagectomy is a surgical procedure for esophageal resection	multi-incision MIE single-incision MIE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival rate	Overall survival rate of the participants after surgery	60 months

Secondary Outcomes

Measure	Description	Time Frame
Pain score as assessed by the face rating scale	The scale range of face rating scale is ranging from 0 (happy face) to 10 (crying face). Higher values represent a worse outcome.	1,7,14,28 days
Ratio of ambulation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jang-Ming Lee, MD PhD	Contact	+886972651439		ntuhlee@yahoo.com
Pei-Wen Yang, PhD	Contact	+88623123456	65123	pwy1210@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jang-Ming Lee	Recruiting	Taipei	Zhongzheng Dist.	100	Taiwan

References Module

Citations

Not provided

Label	URL
previous SIMIE study 1	View source
previous SIMIE study 2	View source

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms