Fetoscopic Laser Photocoagulation for Twin-Twin Transfusion Syndrome

Overseen By Becky Johnson, MS, CCRP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Triplets, higher order multiples

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different surgical techniques affect outcomes in managing twin-to-twin transfusion syndrome, a condition where twins share an uneven blood supply in the womb. The researchers compare two methods surgeons use to enter the uterus during the procedure, aiming to determine if these methods influence the separation of the membranes surrounding the twins. This trial may suit those expecting twins diagnosed with twin-to-twin transfusion syndrome and considering fetoscopic laser photocoagulation (a surgical procedure). As an unphased trial, it offers a unique opportunity to contribute to understanding and improving surgical techniques for this condition.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these entry techniques for fetoscopic laser photocoagulation are safe?

Research has shown that fetoscopic laser photocoagulation, which uses a laser to treat abnormal blood vessel connections between twins, is generally safe for treating twin-to-twin transfusion syndrome. One study found that 6.2% of mothers experienced complications after this surgery, indicating that a small number of mothers had issues related to the procedure.

While this treatment is widely used and has demonstrated good results, it's important to understand that, like any medical procedure, some risks exist. However, it is considered the best option for managing this condition. Prospective trial participants should discuss any concerns or questions with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the techniques used in fetoscopic laser photocoagulation for Twin-Twin Transfusion Syndrome because they offer more precise methods to address this challenging condition. Unlike traditional procedures, these techniques involve minimal invasiveness by using either a sharp trocar or the Seldinger technique to insert a cannula into the uterus. This precision allows surgeons to target the problematic blood vessels with a laser, potentially reducing risks and improving outcomes for both twins. The hope is that these methods will provide safer and more effective interventions compared to existing surgical options.

What evidence suggests that this entry technique is effective for twin-to-twin transfusion syndrome?

Research has shown that a laser treatment called fetoscopic laser photocoagulation effectively treats twin-to-twin transfusion syndrome (TTTS). In one study, 75.4% of pregnancies resulted in both babies surviving after this treatment. Another study found that at least one twin survived in 85.2% of cases. These results suggest that using a laser to close off abnormal blood vessels between twins can greatly improve survival rates. Participants in this trial will undergo fetoscopic laser photocoagulation using either the Direct Entry method or the Seldinger Technique. Overall, fetoscopic laser photocoagulation offers a promising option for managing TTTS. ^{1 3 4 6 7}

Who Is on the Research Team?

Ahmed Nassr, MD, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with monochorionic-diamniotic twin pregnancies experiencing twin-to-twin transfusion syndrome (TTTS) who choose to undergo fetoscopic laser photocoagulation. It excludes those who opt out of the procedure and pregnancies with triplets or more.

Inclusion Criteria

I am choosing laser treatment for my twin pregnancy complication.

Exclusion Criteria

Triplets and higher order multiple gestations.

I chose not to have laser treatment for my twin pregnancy complication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo fetoscopic laser photocoagulation using either direct entry or Seldinger technique

1 day

1 visit (in-person)

Immediate Follow-up

Participants are monitored for chorioamniotic membrane separation and other complications up to hospital discharge

Up to 5 days

Inpatient monitoring

Extended Follow-up

Investigators collect follow-up data on the health of the participant and the babies until the babies turn one month old

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Fetoscopic Laser Photocoagulation

Trial Overview The study investigates how different surgical techniques for entering the uterus affect outcomes in TTTS treatment using fetoscopic laser photocoagulation, focusing on rates of chorioamniotic membrane separation post-procedure.

How Is the Trial Designed?

Group I: Direct Entry Active Control 1 Intervention

Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting a sharp trocar through a small incision in the skin. The trocar is then removed and a small tube called a cannula is left in place.

Group II: Seldinger Technique Active Control 1 Intervention

Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting needle through a small incision in the skin and running a guide wire through the needle so a thin tube called a cannula can be placed over the wire.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

FetNet, a new computer-assisted technique combining CNN and LSTM networks, significantly improves the identification of vascular anastomoses during fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome (TTTS), enhancing surgical precision.

The method demonstrated superior performance over existing techniques, achieving real-time processing at 114 frames per second, which could facilitate safer and more effective interventions during minimally invasive surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FetNet: a recurrent convolutional network for occlusion identification in fetoscopic videos. Bano, S., Vasconcelos, F., Vander Poorten, E., et al.[2021]

The proposed fetoscopic mosaicking method uses deep learning and robust estimation to create detailed images of placental vessels, improving navigation during fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome.

This new approach outperforms existing methods, especially in challenging situations where vessels are poorly visible or too thin, allowing for more effective treatment planning during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robust fetoscopic mosaicking from deep learned flow fields. Alabi, O., Bano, S., Vasconcelos, F., et al.[2023]

Fetoscopic laser photocoagulation (FLP) of placental vascular communicating vessels is feasible and can be performed safely in cases of twin-twin transfusion syndrome (TTTS) after 26 weeks of gestation, with no severe maternal complications reported in a pilot study of six cases.

All fetuses in the study survived beyond 28 days after the procedure, and the median gestational age at delivery was 33.4 weeks, indicating that FLP may improve perinatal outcomes for affected twins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective pilot study of fetoscopic laser surgery for twin-to-twin transfusion syndrome between 26 and 27 weeks of gestation. Nakata, M., Ishii, K., Sumie, M., et al.[2017]

In a study of 19 twin pregnancies with severe twin-twin transfusion syndrome (TTTS), fetoscopic laser therapy using a 1.0 mm endoscope resulted in an overall survival rate of 52.6%, which is comparable to outcomes reported with larger endoscopes.

The therapy was more effective in stage III TTTS, with a survival rate of 61.1% for both twins, compared to 45.0% for stage IV, indicating that earlier intervention may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective fetoscopic laser photocoagulation of superficial placental anastomoses for the treatment of severe twin-twin transfusion syndrome. Ruano, R., Brizot, Mde L., Liao, AW., et al.[2022]

Early fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome at 16 weeks' gestation leads to significantly higher rates of complications such as chorioamniotic membrane separation (34.3% vs 1.3%), preterm rupture of membranes (45.7% vs 25.0%), and chorioamnionitis (11.4% vs 1.3%) compared to procedures performed at 17 weeks or later.

Despite these increased risks, the twin survival rates at birth and 30 days of life were not significantly different between the early laser group and the standard laser group, suggesting that early intervention does not adversely affect survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy outcomes following early fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome at 16 weeks' gestation. Seaman, RD., Salmanian, B., Shamshirsaz, AA., et al.[2023]

In a study of 30 monochorionic twin pregnancies treated with fetoscopic laser coagulation for twin-twin transfusion syndrome, the overall fetal survival rate was 72%, with a 60% survival rate for both twins.

The procedure had a low complication rate, with the most common issue being uterine wall bleeding in 10% of cases, indicating that fetoscopic laser surgery is a relatively safe and effective intervention for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic laser photocoagulation in the management of twin-twin transfusion syndrome: local experience from Hong Kong. Yang, X., Leung, TY., Ngan Kee, WD., et al.[2022]

Fetoscopic laser photocoagulation for treating twin-to-twin transfusion syndrome (TTTS) in 24 procedures showed promising maternal and perinatal outcomes, with a survival rate of 58.3% for donor fetuses until the end of gestation.

The study found that the severity of TTTS, classified by the Quintero system, significantly impacted fetal survival rates, with higher death rates in more severe cases, indicating the importance of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome treatment: initial experience in tertiary reference center in Brazil. Barbosa, MM., Martins Santana, EF., Milani, HJF., et al.[2022]

In a study of 152 cases treated with selective fetoscopic laser photocoagulation for twin-twin transfusion syndrome (TTTS), the overall incidence of complications was significant, with early complications occurring in 31% of cases and late complications in 39%.

Fetal survival rates were high, with 77.5% of fetuses surviving overall and 88% of pregnancies resulting in at least one twin surviving, highlighting the efficacy of the procedure despite the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of complications in twin-twin transfusion syndrome after selective fetoscopic laser photocoagulation: a single-center experience. Habli, M., Bombrys, A., Lewis, D., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11019523/

Perinatal outcomes following fetoscopic laser surgery ... In early TTTS treated with FLS, outcomes were comparable between those treated at <18 weeks compared with ≥18 weeks except for GA at delivery, which was 3 ...

2. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-05997-5

Developmental outcomes for survivors of placental laser ... Of 116 pregnancies (113 twin, 3 triplet), 96 (83%) resulted in 1 + surviving fetuses. 57/113 (50%) twin pregnancies resulted in 2 survivors, 36 ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.27620

Stage‐based recipient and donor outcome in twin‐to‐twin ... The rate of double survival was 88.3% (n = 355) at 48 h after laser therapy, 78.4% (n = 315) at delivery and 75.4% (n = 303) at discharge.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1028455912001192

Short-term outcomes of fetoscopic laser surgery for severe ... Overall survival of TTTS treated by fetoscope had been reported to range from 45% to 70%, and survival of at least one twin ranges from 60% to 85% and higher [6] ...

5. bmrat.org bmrat.org/index.php/BMRAT/article/view/868

Evaluation of the success of fetoscopic laser coagulation in ... Results: Postoperative survival rates at 30 days were 32.2% for both twins, 53% for either twin, and 85.2% for at least one twin. A notable ...

6. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pd.6663

Maternal Complications After Laser Surgery for Twin‐to‐Twin ... In this study, a maternal complication rate of 6.2% was found following fetoscopic surgery for all indications including TTTS. However, data ...

7. mayoclinic.org mayoclinic.org/medical-professionals/obstetrics-gynecology/news/laser-therapy-for-twin-twin-transfusion-syndrome-offers-best-outcomes/mac-20509521

Laser therapy for twin-twin transfusion syndrome offers ... Twin-twin transfusion syndrome can be treated with fetal laser photocoagulation (FLP), which selectively and sequentially ablates connections, depending on the ...