Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

NCT ID: NCT00993837

Last Updated: 2009-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

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Endoscopic thyroidectomy has been used to treat thyroid diseases in China. However, whether this technique is rational to treat thyroid carcinoma is still in controversy. The diagnosis of thyroid carcinoma is predominantly made according to intra-operative frozen section pathological examination in China. In this research, the investigators want to compare clinical index (blood loss, operation duration, number of lymph nodes dissected, complication rates, etc) between patients underwent endoscopic thyroidectomy ( total thyroidectomy) and those underwent conversion to open procedure. The investigators want to evaluate the technical feasibility of endoscopic thyroidectomy for treating thyroid carcinoma.

Detailed Description

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intra-operative diagnosis of thyroid carcinoma is usually considered the indication of conversion to open surgery. with accumulation of experience of endoscopic thyroidectomy, the investigators want to evaluate the technical feasibility, completeness and safety of endoscopic thyroidectomy.

Conditions

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Thyroid Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conversion

Group Type EXPERIMENTAL

thyroidectomy

Intervention Type PROCEDURE

total thyroidectomy via endoscopic approach and that convert to open procedure

Interventions

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thyroidectomy

total thyroidectomy via endoscopic approach and that convert to open procedure

Intervention Type PROCEDURE

Other Intervention Names

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totally endoscopic thyroidectomy

Eligibility Criteria

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Inclusion Criteria

* lesion diameter less than 1 cm by ultrasound

Exclusion Criteria

* frozen section diagnosis indicates benign lesion
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Second Military Medical University

Principal Investigators

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Ming QIU, Dr.

Role: STUDY_CHAIR

Changzheng Hospital affliated to SMMU

Locations

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Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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MIng QIU, Dr.

Role: CONTACT

8621-81885801

Wei ZHANG, Dr.

Role: CONTACT

8621-81885802

Facility Contacts

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Wei ZHANG, Dr.

Role: primary

8621-81885802

Chengxiang SHAN, master

Role: backup

8621-81885804

Other Identifiers

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SMMU-2-2009-3

Identifier Type: -

Identifier Source: org_study_id

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