Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study
17. juni 2026 oppdatert av: The First Affiliated Hospital of Soochow University
Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study
In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
For endoscopic treatment of gastric submucosal tumors originating from the muscularis propria, this study aims to explore whether robot-assisted therapy can improve serosa preservation rate, shorten operative time and reduce complications compared with conventional endoscopic surgery.
Studietype
Intervensjonell
Registrering (Antatt)
110
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Chenhuan Tan
- Telefonnummer: +86 18860928860
- E-post: tanchenhuan2013@163.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Aged 18 to 80 years old;
- Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);
- Tumor diameter ranging from 1.0 cm to 3.0 cm;
- No active ulcer or bleeding on the lesion surface before operation;
- American Society of Anesthesiologists (ASA) physical status class I-III;
- Voluntarily signed written informed consent.
Exclusion Criteria:
- Tumor adhesion to serosa with unclear interface shown on EUS;
- High-risk GIST or distant metastasis indicated by imaging or endoscopy;
- History of gastric surgery or radiotherapy;
- High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;
- Pregnant or breastfeeding women;
- Failure to cooperate with follow-up.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: RG（Robot group）
1.Marking and mucosal incision.2.Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.3.Perform meticulous dissection along the capsule-muscular layer interface using an ESD knife, and preserve the integrity of the serosa as much as possible.4.En bloc resection and removal of the tumor.5.Verification of serosal integrity: The procedure can be completed only if air/water insufflation test shows negative results.
Mucosal defects are closed by standard techniques.
|
After Marking and mucosal incision，Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.
|
|
Aktiv komparator: TG（Traditional Group）
The procedures are performed by surgeons of equivalent seniority via conventional endoscopic full-thickness resection (EFTR) or modified endoscopic submucosal dissection (modified ESD).
If a safe dissection plane cannot be established, full-thickness incision is conducted followed by closure using over-the-scope clip (OTSC), covered stent or suturing techniques.
Leakage is assessed and managed in accordance with standard protocols.
|
Conventional endoscopy without Robot
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serosa integrity rate
Tidsramme: perioperative
|
En bloc resection rate with serosa preserved
|
perioperative
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of the surgical procedure
Tidsramme: Intraoperative
|
Total duration of the surgical procedure
|
Intraoperative
|
|
Dissection time
Tidsramme: perioperative
|
Dissection time of tumor
|
perioperative
|
|
Intraoperative blood loss
Tidsramme: perioperative
|
Intraoperative blood loss during surgury
|
perioperative
|
|
Postoperative fever rate
Tidsramme: Within 7 days after surgery
|
Postoperative fever is defined as a body temperature ≥ 37.5 ℃ within 7 days after surgery.
All febrile cases during this period are included, including non-infectious absorption fever.
|
Within 7 days after surgery
|
|
Postoperative infection
Tidsramme: Within 30 days after surgery
|
Postoperative infection is diagnosed when body temperature reaches ≥ 38.5 ℃, or temperature ≥ 38.0 ℃ persists for more than 3 consecutive days starting from postoperative day 3. Diagnosis shall be confirmed by clinical symptoms, abnormal laboratory inflammatory indicators or positive microbial culture results.
Simple absorption fever is excluded.
|
Within 30 days after surgery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Rui Li, The First Affiliated Hospital of Soochow University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
30. juni 2028
Datoer for studieregistrering
Først innsendt
13. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
18. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2026250
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The shared datasets cover all collected de-identified individual participant data related to this trial, such as demographic data, imaging findings, surgical data, complication records and pathological results.
No personal identifiable information will be retained.
Data will be available to qualified researchers for legitimate scientific research use.
IPD-delingstidsramme
Beginning 6 months after publication of study results and ending 2 years thereafter
Tilgangskriterier for IPD-deling
Access is limited to qualified researchers for legitimate scientific research purposes.
All de-identified IPD and selected supporting documents are available.
Researchers need to submit a formal application, and data will be provided upon approval.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
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