A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)

NCT ID: NCT03804762

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2018-12-20

Brief Summary

The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage of the methodology of the third space, making it possible to dissect gastric GISTs (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid operation.

Conditions

Gastric Soft Tissue Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients received treatment of TS-RECS

Group Type: EXPERIMENTAL

the third space robotic and endoscopic cooperative surgery

Intervention Type: PROCEDURE

This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.

Interventions

the third space robotic and endoscopic cooperative surgery

This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with gastric GISTs originating from muscularis propria diagnosed by EUS (endoscopic ultrasound)；
• The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal cross-sectional diameter of tumor <2cm but with malignant potential ( irregular shape, cystic space, heterogeneity and rapid growth during follow-ups ) ；
• No evidence of tumor metastasis on all per-operative evaluations；

Exclusion Criteria

• 1. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension;
• 2. Patients with advanced malignant tumor;
• 3. Patients were required the emergency operation by complete intestinal obstruction, perforation and hemorrhage caused by the tumor;
• 4.Patients with ulcer penetration into tumors;
• 5. Patients with the contraindications for general anesthesia;
• 6. Patients were pregnant or younger than 18 years old；

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junjun She, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

the First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Countries

China

References

Shi F, Li Y, Pan Y, Sun Q, Wang G, Yu T, Shi C, Li Y, Xia H, She J. Clinical feasibility and safety of third space robotic and endoscopic cooperative surgery for gastric gastrointestinal stromal tumors dissection : A new surgical technique for treating gastric GISTs. Surg Endosc. 2019 Dec;33(12):4192-4200. doi: 10.1007/s00464-019-07223-w. Epub 2019 Oct 17.

Reference Type: DERIVED

PMID: 31624942 (View on PubMed)

Other Identifiers

XJTU1AF2018LSK-168

Identifier Type: -

Identifier Source: org_study_id