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Completed

NCT Number: NCT03804762

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

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.

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Key information

Conditions

Gastric Soft Tissue Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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；

Treatment and study plan

the third space robotic and endoscopic cooperative surgery

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.

Primary outcomes

  1. the rate of adverse events

    Time frame: through study completion, an average of 6 months

    Adverse events included intraoperative adverse (full-thickness perforation, hemorrhage, injury of visceral organs and vessel, and anaesthesia complications), and postoperative adverse events (infectious complications, intra-abdominal /intraluminal bleeding, gastric stasis and leakage)

Secondary outcomes

  1. rate of en bloc resection

    Time frame: 1 day

    the en bloc resection was defined as complete tumor resection with negative surgical margin.

  2. the rate of intact mucosal layer

    Time frame: 1 day

    intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation

  3. operation time

    Time frame: 1 day

    Operation time was defined from the time of docking to the time of trocar incision closure.

  4. estimated blood loss

    Time frame: 1 day

    Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.

  5. time to oral diet

    Time frame: 30 days

    time to oral diet to assess the postoperative course.

  6. duration of postoperative hospital stay

    Time frame: 30 days

    From the day of operation to the day of discharged, duration of postoperative hospital stay to assess the postoperative course.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 15, 2019
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.