Robotic Resection for Patients With Gastric Gastrointesti... | NCT03238820

Studies
Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study

NCT03238820

Sponsor

JIANG Zhi-Wei

Status

Completed

Last Update Posted

Aug 3, 2017Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Gastrointestinal Stromal Tumor of Stomach

Interventions

Robotic gastric gastrointestinal stromal tumors resection

Countries

China

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2014Actual

Primary Completion Date

Aug 5, 2016Actual

Completion Date

Jun 1, 2017Actual

First Submitted Date

Jul 27, 2017

First Submission Date that Met QC Criteria

Jul 31, 2017

First Posted Date

Aug 3, 2017Actual

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

Jul 31, 2017

Last Update Posted Date

Aug 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

Detailed Description

Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract. Approximately 60% of tumors develop in the stomach.Before, patients with gastric gastrointestinal stromal tumors would receive open or laparoscopic surgery. However, gastrointestinal stromal tumors located at special sites, such as cardia, were hardly treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then, we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The robot group	Experimental	Patients undergo robotic gastric gastrointestinal stromal tumors resection.	Procedure: Robotic gastric gastrointestinal stromal tumors resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic gastric gastrointestinal stromal tumors resection	Procedure	Robotic gastric gastrointestinal stromal tumors resection	The robot group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications	Intraoperative and postoperative complications	1 month

Secondary Outcomes

Measure	Description	Time Frame
Blood loss	Blood loss	1 day
Operative time	Operative time	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.
American Society of Anesthesiologists (ASA) physical status I-III.
Participants can follow the visit plan.

Exclusion Criteria:

Patients certified by a doctor that doesn't fit to participate in this study.
Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
Patients with gastrointestinal stromal tumor with distant metastasis.
Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
Patients with gastrointestinal operations and complicated abdominal operations.
Patients with severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, Subjective Global Assessment (SGA) classification C, body mass index <18, Hb<70g/L).
Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
Patients participated other subjects 3 months before this subject.
Sponsors or researchers directly involved in the testing or their family members.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhi-Wei JIANG, Ph.D.	Jinling Hospital, Medical School of Nanjing University	Principal Investigator
Jian ZHAO, Ph.D.	Jinling Hospital, Medical School of Nanjing University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinling Hospital, Medical School of Nanjing University		Nanjing	Jiangsu	210002	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The results and IPD might be considered to share in published articles.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms