Percutaneous laser therapy for fetal tumours (interventional procedures consultation document)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Percutaneous laser therapy for fetal tumours

The National Institute for Health and Clinical Excellence is examining percutaneous laser therapy for fetal tumours and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous laser therapy for fetal tumours.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.

The Advisory Committee will then prepare draft guidance which will be the basis for the Institute’s guidance on the use of the procedure in the NHS in England, Wales and Scotland.

Closing date for comments: 28 March 2006

Target date for publication of guidance: June 2006


Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.


1 Provisional recommendations
1.1

Current evidence on the safety and efficacy of percutaneous laser therapy for fetal tumours does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

1.2

Clinicians wishing to undertake percutaneous laser therapy for fetal tumours should take the following actions.

    • Inform the clinical governance leads in their Trusts.
    • Ensure that parents understand the uncertainty about the procedure’s safety and efficacy. Clinicians should provide parents with clear written information, and counselling support both before and after the procedure. In addition, use of the Institute’s Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo
    • Audit and review clinical outcomes of all patients having percutaneous laser therapy for fetal tumours
1.3 This procedure should only be performed in centres specialising in invasive fetal medicine and in the context of a multidisciplinary team that includes a consultant in fetal medicine, a midwife, a neonatologist and a paediatric surgeon.
1.4 All patients should be entered onto the European Commission registry (www.eurofoetus.org/index.htm), which has been endorsed by the British Maternal and Fetal Medicine Society .
1.5 Publication of safety and efficacy outcomes will be useful. The Institute may review the procedure on publication of further evidence.


2 The procedure
2.1 Indications
2.1.1 Sacrococcygeal teratomas and congenital cystic adenomatoid malformations (C CAM) are usually benign tumours, although teratomas may also be malignant. These tumours can become very large and highly vascular, causing stress on the heart of the fetus. This can lead to the development of non-immune hydrops fetalis (in utero heart failure) and may be complicated by polyhydramnios (excessive accumulation of amniotic fluid). Non-immune hydrops fetalis, placentomegaly, cardiomegaly, large tumour size and high tumour growth rate are associated with poor prognosis, and fetal mortality is high. Obstetric complications include pre-term labour and dystocia.
2.1.2

The current treatment options in managing pregnancies with these fetal tumours include: termination of the pregnancy; continuation of the pregnancy without intervention; or early elective caesarean delivery if significant problems develop. For the latter, the prognosis is poor even when the fetus is approaching term.

2.2 Outline of the procedure
2.2.1

Percutaneous laser therapy for fetal tumours is performed under maternal local anaesthesia and light sedation by inserting a needle under ultrasonographic guidance through the mother's abdomen into the uterine cavity. An analgesic is then injected subcutaneously or intramuscularly into the fetus before advancing the needle to the site of the tumour. Colour-Doppler imaging is used to guide placement of the needle. A laser fibre is passed through the needle lumen and laser energy is then delivered in pulses, causing the blood vessels within the tumour to coagulate. If necessary, laser therapy may be repeated in a further session, usually 1 or more weeks later. During the procedure, cystic components of tumours may be aspirated

 
2.3 Efficacy
2.3.1

The efficacy and safety of the procedure are based on reports on three fetuses: two with CCAM and one with sacrococcygeal teratoma.

2.3.2 In a case series of 67 fetuses that were diagnosed with cystic lung abnormalities, one fetus received two treatments of percutaneous laser therapy. Reductions in non-immune hydrops, mediastinal shift, ascites and the blood flow within the tumour were reported following the first treatment. The neonate was delivered at 38 weeks’ gestation, with surgical excision of the tumour performed after birth. (Death occurred 4 days after birth because of sepsis-related complications.)
2.3.3 In one case report, a fetus with CCAM received two treatments of percutaneous laser therapy: the first treatment at 23 weeks’ gestation, and the second treatment 1 week later. Both treatments had to be terminated early because of fetal bradycardia. Reduction in tumour size was reported following the first treatment. No outcomes were reported following the second treatment except that the fetal heart tracing was normal immediately after the treatment. (However, fetal death in utero was confirmed 3 days after the second treatment.)
2.3.4 In another case report a fetus with sacrococcygeal teratoma received two treatments of percutaneous laser therapy. Increase in tumour size was reported following the first treatment, whereas the size of the tumour was similar before and after the second treatment. Moderate increase in tumour size occurred during the remainder of the pregnancy. The neonate was reported to be healthy and developing normally at 8 months of age. For more details, refer to the sources of evidence (see Appendix).
2.3.5

The Specialist Advisors stated that there is uncertainty about the effectiveness of the procedure. Key efficacy outcomes include decrease in the vascularity of the fetal tumour leading to potential shrinkage of the tumour in utero and decrease in cardiac failure in the fetus.

 

2.4 Safety
2.4.1

In the case series of 67 fetuses with cystic lung abnormalities, one fetus received two treatments of percutaneous laser therapy. Neonatal death resulting from sepsis-related complications was reported 4 days after birth in this fetus.

2.4.2 In a case report of a fetus with CCAM, worsening of non-immune hydrops was reported 4 days after the first treatment. Three days following the second treatment (at a scheduled visit), fetal death in utero was diagnosed.
2.4.3 In another case report of a fetus with sacrococcygeal teratoma, bleeding (possibly within the cystic area) occurred following the first treatment, which required intrauterine blood transfusion. Drainage of blood from the cystic area and drainage of amniotic fluid were performed during the second treatment. The neonate was delivered by elective caesarean section at 37 weeks’ gestation, with surgical excision of the tumour performed after birth. For more details, refer to the sources of evidence (see Appendix).
2.4.4 The Specialist Advisors stated that theoretical risks include haemorrhage and procedure-related fetal death. There are also uncertainties about the harmful effects of the procedure on other anatomical areas. The theoretical risks to the mother include pre-term labour following the procedure and laser burn if the needle is not sited correctly.
2.5 Other comments
2.5.1 It was noted that the procedure might also be used to treat other fetal tumours such as cystic hygromas.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2006

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

This page was last updated: 04 February 2011