Fetoscopic Repair for Gastroschisis
Recruiting in Palo Alto (17 mi)
Overseen bySundeep Keswani, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Baylor College of Medicine
Must not be taking: Antibiotics
Disqualifiers: Fetal anomaly, Preterm labor, Placental abnormalities, High BMI, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial aims to test a new surgery for unborn babies with severe bowel issues where their intestines are outside their belly. The surgery is done through a small opening in the mother's womb using a camera and tiny tools. This method hopes to reduce complications after birth compared to traditional treatments.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What data supports the effectiveness of the treatment Fetoscopic Repair for Gastroschisis?
Research suggests that fetoscopic surgery, which involves minimally invasive techniques to repair the condition before birth, may help reduce bowel damage and complications in complex gastroschisis. Advances in prenatal diagnosis and fetoscopic techniques have shown potential benefits, although more research is needed to confirm these findings.
12345Is fetoscopic repair for gastroschisis safe for humans?
Research suggests that fetoscopic repair for complex gastroschisis may be safe when performed in expert fetal centers, as recent advances in prenatal diagnosis and fetoscopic surgery have improved maternal and fetal safety.
13467How is the fetoscopic repair treatment for gastroschisis different from other treatments?
Fetoscopic repair for gastroschisis is unique because it involves a minimally invasive surgical approach performed before birth to reposition the bowel and close the abdominal defect, potentially preventing bowel damage and complications that occur with traditional postnatal treatments.
128910Eligibility Criteria
This trial is for pregnant women over 18 with a single pregnancy between 20-25 weeks, where the fetus has gastroschisis. Candidates must have normal genetic tests and no significant unrelated anomalies or maternal health issues that could complicate surgery.Inclusion Criteria
My family and I have decided against ending the pregnancy before 24 weeks or standard treatment after birth.
Parental/guardian permission (informed consent) for follow up of the child after birth
Intraabdominal bowel dilation ≥ 10 mm at 20-24 weeks GA reviewed by prenatal ultrasound
+7 more
Exclusion Criteria
Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
Placental abnormalities (previa, abruption, accreta) known at time of enrollment
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Fetoscopic Surgical Repair
Participants undergo minimally invasive in-utero repair of complex gastroschisis via a fetoscopic surgical approach
Surgical procedure
1 visit (in-person)
Post-Surgery Monitoring
Participants are closely followed with ultrasound and consultation after the surgery
Until delivery
Multiple visits (in-person)
Follow-up
Infants are monitored for safety and effectiveness after birth, including neuro-developmental outcomes and survival
12 months
Regular follow-ups (in-person)
Participant Groups
The study is testing the safety and feasibility of repairing complex gastroschisis in unborn babies using fetoscopy—a surgical procedure performed on the fetus. The aim is to see if this can reduce death and complications after birth.
1Treatment groups
Experimental Treatment
Group I: fetoscopic surgical repairExperimental Treatment1 Intervention
Single arm study. All patients will receive the fetoscopic repair.
Fetal Repair of Complex Gastroschisis is already approved in United States for the following indications:
🇺🇸 Approved in United States as Fetal Repair of Complex Gastroschisis for:
- Complex Gastroschisis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas Children's HospitalHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
References
Complex gastroschisis: a new indication for fetal surgery? [2021]Gastroschisis (GS) is a congenital abdominal wall defect, in which the bowel eviscerates from the abdominal cavity. It is a non-lethal isolated anomaly and its pathogenesis is hypothesized to occur as a result of two hits: primary rupture of the 'physiological' umbilical hernia (congenital anomaly) followed by progressive damage of the eviscerated bowel (secondary injury). The second hit is thought to be caused by a combination of mesenteric ischemia from constriction in the abdominal wall defect and prolonged amniotic fluid exposure with resultant inflammatory damage, which eventually leads to bowel dysfunction and complications. GS can be classified as either simple or complex, with the latter being complicated by a combination of intestinal atresia, stenosis, perforation, volvulus and/or necrosis. Complex GS requires multiple neonatal surgeries and is associated with significantly greater postnatal morbidity and mortality than is simple GS. The intrauterine reduction of the eviscerated bowel before irreversible damage occurs and subsequent defect closure may diminish or potentially prevent the bowel damage and other fetal and neonatal complications associated with this condition. Serial prenatal amnioexchange has been studied in cases with GS as a potential intervention but never adopted because of its unproven benefit in terms of survival and bowel and lung function. We believe that recent advances in prenatal diagnosis and fetoscopic surgery justify reconsideration of the antenatal management of complex GS under the rubric of the criteria for fetal surgery established by the International Fetal Medicine and Surgery Society (IFMSS). Herein, we discuss how conditions for fetoscopic repair of complex GS might be favorable according to the IFMSS criteria, including an established natural history, an accurate prenatal diagnosis, absence of fully effective perinatal treatment due to prolonged need for neonatal intensive care, experimental evidence for fetoscopic repair and maternal and fetal safety of fetoscopy in expert fetal centers. Finally, we propose a research agenda that will help overcome barriers to progress and provide a pathway toward clinical implementation. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.
Influence of amnioinfusion in a model of in utero created gastroschisis in the pregnant ewe. [2017]Recent studies on the management of human fetal gastroschisis have produced two major findings: (1) there is an inflammatory response in the amniotic fluid of these fetuses, and (2) amniotic fluid exchange designed to disrupt the inflammatory loop seems to have a favorable impact on the immediate and late outcome of these early operated neonates. To test this hypothesis, we used serial amniotic fluid exchanges in a model of gastroschisis developed in the ewe.
Surgical strategies in complex gastroschisis. [2018]Currently, the most important determinant of gastroschisis outcomes in high resource settings is whether the condition is associated with intestinal complications, such as atresia, necrosis, perforation, or volvulus. This form of the anomaly, known as complex gastroschisis, accounts for most of the mortality and a disproportionate burden of the morbidity from gastroschisis. There is some disagreement about what constitutes complex gastroschisis, and little consensus on the type and timing of surgical interventions. This article establishes a clear definition of complex gastroschisis. Surgical approaches to treatment of the diverse presentations of complex gastroschisis will be described and the timing of such interventions will be discussed. Contemporary outcomes of complex gastroschisis will be reviewed. Finally, a non-congenital intestinal complications that may arise in gastroschisis patients will be discussed.
Complex gastroschisis is a different entity to simple gastroschisis affecting morbidity and mortality-a systematic review and meta-analysis. [2018]Comparison of the outcome of newborns with simple (sGS) and complex gastroschisis (cGS: gastroschisis with atresia, necrosis, perforation or volvulus).
[Gastroschisis: Prenatal ultrasonography and obstetrical criteria for predicting neonatal outcome]. [2017]Prenatal diagnosis of complex laparoschisis is difficult and yet it is associated with a significantly increased morbidity and mortality. The aim of the study was to define ultrasonographic factor and obstetrical criteria to predicting adverse neonatal outcome.
A randomised controlled trial of amnioexchange for fetal gastroschisis. [2022]Morbidity in fetuses affected by gastroschisis is mainly the result of bowel ischaemic and inflammatory processes. Experimental studies on animal models show that clearing amniotic fluid from the digestive secretions by amnioexchange procedures reduces the inflammatory process. We evaluated the benefit of the amnioexchange procedure for fetal gastroschisis in humans.
Prenatal management of gastroschisis: the place of the amnioexchange procedure. [2019]Gastroschisis is a malformation of the anterior abdominal wall that consists of a right paraumbilical defect with bowel loops bathed in the amniotic fluid. The survival rate is now greater than 90% and the prognosis relies mainly on morbidity attributable to bowel dysfunction. Recent research has examined gastrointestinal waste present in amniotic fluid that induces bowel toxicity and an inflammatory process. The amnioexchange procedure (changing the amniotic fluid regularly) involves a new therapeutic approach: reducing bowel injuries in the fetuses. This article shows that there is an inflammatory reaction in human gastroschisis and in the authors' model, and that the clinical and biological data plead for the practice of amnioexchange in human beings. A randomized, controlled study is now needed.
Fetoscopic management of gastroschisis in a lamb model. [2021]Gastroschisis is a malformation consisting of an abdominal wall defect with eviscerated bowel. Its standard treatment is postnatal repositioning or temporary prosthetic bag placement. The aim of our study is to evaluate the feasibility of its fetoscopic management in a lamb model.
Fetal Surgery for Gastroschisis-A Review with Emphasis on Minimally Invasive Procedures. [2022](1) Background: The morbidity of gastroschisis is defined by exposure of unprotected intestines to the amniotic fluid leading to inflammatory damage and consecutive intestinal dysmotility, the viscero-abdominal disproportion which results in an abdomen too small to incorporate the herniated and often swollen intestine, and by associated pathologies, such as in complex gastroschisis. To prevent intestinal damage and to provide for growth of the abdominal cavity, fetal interventions such as amnio exchange, gastroschisis repair or covering have been evaluated in several animal models and human trials. This review aims to evaluate the reported techniques for the fetal treatment of gastroschisis by focusing on minimally invasive procedures. (2) Methods: We conducted a systematic database search, quality assessment and analyzed relevant articles which evaluate or describe surgical techniques for the prenatal surgical management of gastroschisis in animal models or human application. (3) Results: Of 96 identified reports, 42 eligible studies were included. Fetal interventions for gastroschisis in humans are only reported for EXIT procedures and amnio exchange. In animal models, particularly in the fetal sheep model, several techniques of open or minimally invasive repair of gastroschisis or covering the intestine have been described, with fetoscopic covering being the most encouraging. (4) Discussion: Although some promising minimally invasive techniques have been demonstrated in human application and animal models, most of them are still associated with relevant fetal morbidity and mortality and barely appear to be currently applicable in humans. Further research on specific procedures, instruments and materials is needed before any human application.
Fetoscopic techniques for prenatal covering of gastroschisis in an ovine model are technically demanding and do not lead to permanent anchoring on the fetus until the end of gestation. [2021]This is the cumulative technical report on the operative procedures and limitations of fetoscopic bag insertion, intestinal bag placement, and bag fixation to the fetus in a series of pilot studies in an ovine model for prenatal treatment of gastroschisis.