endothef - endovascular treatment of hemorrhoids with foam - uip boston, 2013

EndoTHeF: Endovascular Treatment of

Hemorrhoids with Foam

M. Ronconi, M.D.

E. Cervi, M.D.

A. Frullini, M.D.

XVII°World Meeting

of the

Union Internationale de Phlébologie

Polidocanol foam as referred to in this talk

has not been approved for use by the

Federal Drug Administration (FDA).

Disclosure of

conflicts of interest

I do not have any relevant financial relationships with any commercial interests.

Disclosure of non-FDA

approved drugs

Maurizio Ronconi, M.D.

• Haemorrhoids are normal anatomical structures present in healthy

people from birth, recognizable even in uterine life.

• When these vascular cushions generate symptoms, we erroneously

speak of “haemorrhoids”

When we use the term “haemorroids” we

generally refer to the symptoms caused by

haemorrhoids

Misunderstanding

• Bleeding, anemization

• Prolapse

» ulceration

»sepsis

»strangulation

• Pain

• Thromboflebitis

• Pruritus

Most frequent symptoms

Epidemiology

Western countries:

- 5% of the whole population is affected by haemorrhoids

USA:

- 10 million people complained of haemorrhoids, leading to

a prevalence rate of

4.4% (National Center for Health Statistics)

Italy

- there are 1,000,000 new cases per year

(2% of the population)

- every year 35,000 operations are carried out to

treat

haemorrhoidal diseases

Classification of internal hemorrhoids

• 1st grade : venous ectasies which bleed, but do not prolapse

• 2nd grade: haemorrhoidal prolapse during defecation, spontaneously reductable

• 3rd grade: haemorrhoidal prolapse during defecation, reductable only manually

• 4th grade: permanent external haemorrhoidal prolapse, non reductable

Goligher, 1975

Option therapy

medical topical medication

orally administered medication

surgical

Milligan-Morgan haemorrhoidectomy

Ferguson haemorrhoidectomy

haemorrhoidopexy using a stapler

Transanal Haemorrhoidal Dearterization (THD)

rubber band ligation

diathermal coagulation

sclerotherapy

outpatient care

Mean volume per knot:

•0.93 ml (first session)

•0.5 ml (others sessions)

abandoned for the high

number of relapses

2nd European Consensus Meeting on Foam Sclerotherapy -Tegernsee, Germany

F. X. Breu et al., Supplement 71, February 2008, 3 VASA 2008; S/71: 3–29

Monitoring of the vital functions using an oxypulsemeter

Technique

Patient in left lateral position

• Rectal exploration

• Introduction of the endoscope into the rectum

• “retroversion” (or inversion) manoeuvre

• Visualization of the hemorrhoidal plexus origin

• puncure into the haemorroid with a 25g needle

Injecting the 3% Polidocanol foam, prepared in according to Tessari

method:

- two luer-lock syringes (10 and 5 cc)

- 3-way cock

- gas (air)/liquid 4:1

- 20 passages using 2 syringes alternatively.

max 3 cc. foam / each globe

max 8 cc foam /session

new session after 3 weeks

usually at least 3 sessions

Protocol

EndoTHeFEndovascular Treatment of Hemorrhoids with Foam

Average duration

8 minutes (range 5-12).

Direct injection

Direct injection of hemorrhoids

CasesJanuary 2009 – June 2013

290 patients rectal bleeding

No. %

males 122 58,1

females 88 41,9

80 exluded for other causes of bleeding

210 enrolled

No. %

1st grade 5 2.5

2nd grade 108 51.4

3rd grade 86 40.9

4th grade 11 5.2

12 patients, already operated on:

6 - Longo

5 - Milligan-Morgan

1 - double Millogan-Morgan + Longo.

32 patients (12,7%)

severe hypocromic microcytic anaemia

( Hgb < 8 g/dL, MCV < 70)

Characteristics of the patients according to the Goligher

classification

Results

765 procedures in 210 patients( means: 3.6 sessions per patient)

Follow-up

12 cases (4,8%) : more than five sessions due to persistant bleeding

2 cases: patients opted for surgical haemorrhoidectomy.

32 patients suffering from severe anaemia

- 3 transfusion of two units of autologous blood

- 29 normalization of haematocrit within 30 days after the 1st treatment

Disappearance of rectal bleeding in

83% of the cases

after the first session

176 patients available

(means: 12 months)

4 patients (1.6 %): local itching

6 patients (1.8 %): local heaviness for a week after

treatment

Adverse effect

No major complications

No major side-effects

Score

4 3 2 1

Bleeding > 1 episode/week < 1 episode/week <1 episode/month never

VAS* 10-8 7-5 4-2 1-0

Discomfort alwais > 7 days/month < 7 days/month <3 days/month

Information obtained insufficient sufficient exhaustive

reasons for recommending the method

Before the first procedure

Before the first procedure and after the last procedure

Questionnaire

After the last procedure

*VAS : visual analogue scale for pain

insufficient sufficient exhaustive

Information obtained - 2.4% 97.6%

Answers to the questionnaire

Reason for recommending the method

Stop the bleeding 98.8%

Absence of pain 98.3%

Get back to usual activities within a day 94.7%

Answers to the questionnaire

proctorragy VAS discomfort

P< 0,0015

Conclusions

• simple, feasable and safe procedure

• painless procedure

• good control of symptoms

Foam endoscopic sclerotherapy:

Recurrence rate

Prospective, randomized, multicentric study needed

?

2. What’s the recurrence rate of hemorrhoids after

hemorroidectomy?

1. Wich are complications after

hemorroidectomy?

Open questions

1. Wich are complications after hemorroidectomy?

2. What’s the recurrence rate of hemorrhoids

after hemorroidectomy?

Open questions

To cure or to operate hemorrhoids…

… that is the question