Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome

Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome (TTTS)

The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.

Study Overview

• Status: Recruiting
• Conditions: Monochorionic Diamniotic Placenta; Twin to Twin Transfusion as Antepartum Condition
• Intervention / Treatment: Procedure: Fetoscopic laser ablation

Detailed Description

Patients will undergo an intake evaluation followed by a detailed ultrasound examination to rule out the presence of congenital anomalies and to assess the hemodynamic status of the fetuses and any pre-existing cerebral damage. The following data will be collected, as is identical to the standard of care in evaluating monochorionic twins

Maternal

• Age
• Gravidity and parity
• BMI
• Race/ethnicity
• Gestational age
• The presence of any symptoms
• Cervical length

Fetal

• Estimated fetal weight
• Detailed anatomy
• Doppler evaluation of umbilical cord, ductus venosus and middle cerebral arteries
• Evaluation of the myocardial performance indices
• Amniotic fluid volume
• Placental position
• Cord insertions

Patients will then be counseled about the risks and benefits of the procedure and will be asked to sign an informed consent.

The procedure will be performed under a spinal or local anesthesia at the discretion of the anesthesiologist and surgeon based upon placental position, maternal hemodynamic stability and maternal anxiety and ability to cooperate. Ultrasound guidance will help to select an appropriate incisional site. Under ultrasound guidance, a 2 mm skin incision will be made and a 10 French Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. An amniotic fluid sample will be obtained and sent for microbiological studies. A small aliquot of fluid will also be set aside for future institutional review board approved studies (see detail regarding banking below).

The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope. The Laser used is a Dornier Diode laser using a power of 30-40 Watts. At the conclusion of the anastomotic ablation, an ablation line will be created across the vascular equator, effectively dichorionizing the placenta. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be documented at the beginning and end of the procedure. An amniodrainage of the larger sac will be performed at the conclusion of the procedure to leave the amniotic fluid volume of that sac at a normal level.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Martin P Walker, MD; Phone Number: 73539 206-987-3539; Email: martin.walker@seattlechildrens.org
• Study Contact Backup: Name: Melissa Dorn, RN MN; Phone Number: 74137 206-987-4137; Email: melissa.dorn@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Active, not recruiting
      • University of Washington
    • Seattle, Washington, United States, 98015
      • Recruiting
      • Seattle Childrens Hospital
      • Contact: Martin P Walker, MD; Phone Number: 73539 206-987-3539; Email: martin.walker@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant persons presenting with a diagnosis of twin to twin transfusion syndrome

Description

Inclusion Criteria:

• Single placenta (Monochorionic)
• Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)
• Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)
• Prominent bladder in the recipient/ non-filling bladder in the donor
• Thin dividing membrane

Exclusion Criteria:

• Patients unwilling to participate in the study or to be followed up
• Presence of major congenital anomalies incompatible with survival
• Active pre-term labor Ruptured membranes
• Chorioamnionitis
• Vaginal bleeding

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients presenting with TTTS; Pregnant persons between 16 and 36 weeks of pregnancy with a diagnosis of twin to twin transfusion syndrome

Procedure: Fetoscopic laser ablation; Under ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival to discharge from the nursery of affected babies	Immediately after the surgery to discharge from the hospital after delivery

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Martin P Walker, MD, Seattle Childrens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Laser; Twin; Fetoscopy; Monochorionic
• Additional Relevant MeSH Terms: Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Anemia, Neonatal; Fetofetal Transfusion
• Other Study ID Numbers: 00003168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No