Long-Term Outcome of Endoscopic Balloon Dilation in Obstructive Gastrointestinal Crohn's Disease: A Prospective Long-Term Study

Background The short- and long-term results of balloon dilation therapy in Crohn's patients with non-anastomotic obstructive gastrointestinal lesions are investigated. Materials and methods Fifty-five patients with Crohn's disease who had obstructive gastrointestinal lesions were treated prospectively by endoscopic balloon dilation. Short-term results Eight of the initial dilations were unsuccessful giving no symptomatic relief (14.5%). Long-term results The subjects of the long-term prognosis were 40 cases followed up for more than 6 months (average 37 months) and their strictures were non-anastomotic in more than half (59%). Avoidance of surgery, was possible in 31 of 40 patients (78%). Surgery was avoided in 92%, 81% and 77% of patients after one, two, and three years, respectively (Kaplan–Meier's method). There was no difference in long-term outcome between anastomotic strictures and strictures in the absence of prior surgery. Conclusion Our results suggest that, (1) strictures in the absence of prior surgery might be treated in this way as well as anastomotic strictures; (2) if followed for a prolonged time period, more than 70% of patients, who have undergone balloon dilation for obstructive gastrointestinal Crohn's disease, may be able to avoid surgery.


irty-two of the 55 pa
ients were male.Age at the onset of gastrointestinal symptoms was ranged from 15 to 36 years (average 26.6).The diagnosis of Crohn's disease was confirme endoscopically, radiographically or histologically.Before obstruc- tive symptoms occurred, their disea e had been followed for an average of 7.9 years (range 0.8- 10.0).They were classified into 14 small intestinal (6 gastroduodenal), 34 ileocolitis, and 7 colitis type cases.At the time of dilation 32 (58%) had pre- viously undergone surgery.Six patients had gas- troduodenal stenoses and 49 patients had ileocolic stenoses.At the time of dilation 45 patients had mild to severe obstructive symptoms and 10 did not have obvious obstructive symptoms but had severe strictures which an endoscope was not able to pass through.These 10 patients had been reciev- ing nutritional therapy (total parenteral nutrition or elemental diet) for active diseases for several weeks and were on nil by mouth.After disease activity had settled down to remission stage (CDAI < 150), colonoscopic evaluation revealed severe stenosis in these patients.They did not have obstructive symptoms because they had not ingest an ordinary diet yet.Seven of the ten asymptomatic patients turned out to be symptomatic during follow-up when on a regular diet.


Indications for Dilation

Indications for balloon dilation were as follows:

(1) patients who had strictures in gastroduodenal lesions or ileocolonic lesions, (2) the activity of the disease was quiescent (CDAI < 150, in 48) or not highly active (150 < CDAI < 250, in 7), (3) their general c

dition was not extremely
oor and severe complications (abscess, severe fist la, deep ulcers) were lacking.However, patients with occult fistula or fine fistula were included, (4) patients agreed to the procedure.Informed consent was obtained from all patients.Most of the patients had obstruc- tive symptoms, however, asymptomatic patients who had severe stenosis under nutritional therapy were thought to be indicated for this therapy.

Morphological characteristic of lesions in the 55 patients were recorded mainly by pre-and post- dilation radiography using location, length, angula- tion, with or without oral luminal dilatation, waist size of balloon at maximal dilation, anastomotic or non-anastomotic and concomitant fistul as measures.


Balloon Dilation Technique

Balloon dilation was performed using 10 and 20mm balloons (Rigiflex, Microvasive, Milford, Mass.), through a GIF-XQ-30 endoscope for upper-gastrointestinal and a CF-200I endoscope (both Olympus Optical Company, Tokyo, Japan) for lower intestinal stenoses as no

d before [33].Diazepam was
sed to sedate patients.Our endo- scopic approach was to start with a small throughthe-scope (TTS) balloon, then proceed to a larger size and finally to use a large over-the-wire (OTW) balloon, with the progression based on the radio- graphic and clinical responses of the patients to the dilation.Each dilation session consisted of two to four 5 min inflations of each balloon size used.Under fluoroscopic guidance, the balloon or the guide wire was advanced as far as possible through the stricture and into the distal side.When using an OTW balloon, the endoscope was removed and the balloon catheter was advanced over the guide wire through the stricture.We performed maximal dila- tion over a few days (separate dilation two or three times) by a way of progressively stretching the strictured lesions.At the initial dilation a small balloon was used with a larger one at the second dilation.Finally, we targeted a maximum diameter of 2 mm in all stenoses under a pressure of control between 20 and 30 pounds per square inch.

Post-dilation studies were obtained using diluted barium whe ever possible.The success of the dila- tion was judged strictly on the basis of symptomatic relief.Some of the patients have been prescribed drugs (mesalamine or corticosteriods) and most of the patients were prescribed an enteral nutritional diet before and after the dilation without significant therapeutic changes.Other food restrictions were not enforced during the follow-up.

Follow-Up and Re-Dilation During the follow-up period careful

bservations were made conc
rning symptomatic recurrence.After the first dilation session the 40 patients were followed up for 7-95 months (average 37.0).When obstructive symptoms recurred re-dilations were performed as soon as possible in the outpatient cli- nic or after re-admission.After re-dilation patients were regularly checked and received re-dilation when neccesary in the outpatient clinic.


Analysis of Short-Term and


Long-Term Prognosis

When the firs

cessful because of s
vere, long or highly angulated stenoses, patients were only analyzed in the short-term prog- nosis and were not included as subjects of the longterm analysis.Patients whose follow-up period was less than 6 months were also not included in this study.Forty patients were thus analyzed for long- term prognosis (Fig. 1).Profiles of these are listed Patients with Crohn's disease undergoning balloon d

ation
n=55) Short-term  Follow-up< 6 mo.


cases

Long-term unsuccessful requiring surgery 9 cases


FIGURE

Subjects of the study.Fifty-five patients underwent balloon dilation therapy.Short-term success was attained in 47 patients.Forty patients who were followed up for more than 6 months (average 37.0 months) were the subjects for long-term prognosis.Fi

lly
9 patients (22.5% were operated on. in Table I.They were classified into 11 small intesti- nal (6 gastroduodenal), 23 ileocolitis, and 6 colitis type cases, and at the time of dilation 17 (42.5%)had previously undergone surgery.Patients had 6 gastroduodenal, 6 rectal, 13 colonic, 11 ileocecal, and 4 ileal stenoses.At the time of dilation 30 patients had mild to severe obstructive symptoms and 10 did not have obvious obstr ctive symptoms.

The cumulative avoidance of surgery rate was calculated by the Kaplan Meier's method.

Comparisons between patients who avoided sur- gery (successful) and patients who did not avoid surgery (unsuccessful) were made in respect to back- ground and morphological features.Background features compared were: gender, age at dilation, duration of disease, disease type, site of stricture (upper or lower gastrointestinal tract), and patients with or without symptoms.Morphological and clinical characteristics of the lesions were compared between the two groups as follows: length, with or without angulation, lesion with or without oral luminal dilatation, waist diam- eter on the balloon by radiography, anastomotic or non-anastomotic, the presence of concomitant fis- tula and having recurrence or not.The rate of complication

as also cal
ulated.


Statistics

Chi-square test or Fisher's exact test were used when comparing frequency.Student's t-test was used when comparing mean values.When p value was less than 0.05 the difference was cons

ered sig
ificant.


RESULTS

1 Short-term prognosis Eight cases were unsuc- cessful at the first dilation and so the short-term success rate was 85.5% (Fig. 1).A stricture longer than 3 cm was the main cause of failure.Extremely angulated or edematous lesions were also not able to be dilated successfully.In one patient with colo- nic stenosis, peritonitis with sealed perforation occurred and surgical intevention was necessary. 2Long-term prognosis in relation to background and morphological characteristics Background features of the successful and unsuccessful cases were compared.There were no differences in gen- der, age at dilation, duration of disease, disease type, site of stricture (upper or lower gastrointest- inal tract), and the rate of symptomatic cases (Table II).When comparing the morphological ): number of anastomotic strictures, S: small intestinal, SL: small and large intestinal, L: large intestinal.characteristics of the lesions between the two groups, there were no significant differences in length, with or without angulation, waist diameter on the balloon, anastomotic or non-anastomotic, presence of concomitant fistula and with or with- out oral luminal dilatation.However, patients with recurrent symptoms had a significantly higher fail- ure rate (p < 0.05, Table III).

3 Re-dil tion Symptomatic recurrences oc- curred in 22 patients (55%) during the follow-up period and all these patients received re-dilation.

Ten patients (25%) had more than two recur- rences.Six of these received scheduled dilation every 3-9 months.One hundred and fifteen dila- tions (range: 1-8 times/person) were performed in the 40 patients. 4Long-term avoidance of surgery rate (Fig. 2) Seven patients were operated on because of frequent recurrences or for intractable fistulas, one because of a perforation after the second dilation and one because of massive bleeding unrelated to the dilation procedures (Table IV).From the analysis of the 40 patients, avoidance of surger

was possibl
in 31 (77.5%) and serial rates were calculated as 92% in one, 81% in two, 77% in three and 68% in five years (Fig. 2).  2 The cumulative avoidance of surgery rate after balloon dilation in patients with Crohn's disease (Kaplan-Meier's method).


DISCUSSION

Hydrostatic balloons have been used for dilation of gastrointestinal strictures ofdiverse etiology .Balloon dilation has been successfully performed for Crohn's patients with gastrointestinal obstruc- tive lesions [24][25][26][27][28][29][30][31][32][33].Although there have been some studies which have examined the efficacy of treat- ment of obstructive ileocolonic Crohn's disease by balloon dilation there are very few long-term studies in which dilations were prospectively performed with a large number of cases [27,30].Couckuyt reported that the long-term prognosis of a large number of patients who received balloon dilation was fairly good (at a mean follow-up of 34 months, 34 (62%) patients remained unoperated on) but there was a relatively high complication rate (11%) [30].However, most of the reported Crohn's patients included in Couckuyt's series had anas- tomotic strictures and endoscopic

lloon dial- tion for anastomotic strictures in Crohn
s disease has been considered to be a first-choice modality of treatment.Howev.er,there were no conclusions whether non-anastomotic strictures in Crohn's disease were indicated for balloon dilation or not.Moreover, factors influencing the long-term results

were not fully analyzed.Our previous results, with non-anastomotic gastroduodenal obstructive lesions in Crohn's disease, were satisfactory because of the fairly good long-term patency of the lesion although high rates of recurrence were observed [33].Although different endoscopic approaches were necessary for gastroduodenal and the ileocolic stenoses, there were no obvious differences in dila- tion procedure long-term success rate and the rates of recurrences between the two sites of the stenoses.Including these cases, short and long-term outcomes and the affecting factors were analyzed prospec- tively, especially in the non-anastomotic patients in this study.

Initial dilations were successful in 85.5% of patients in the present study.From a technical point of view, balloon dilation might not produce favor- able results in extremely long or angulated lesions, as our results show and other reports have shown [27,29,31,33].

As for long-term outcomes, our results suggested that if followed for a prolonged period of time, patients who have undergone balloon dilation for obstructive gastrointestinal Crohn's lesions have high (55%) rates of symptomatic obstruction recurrences.However, re-dilations were successful in most of the patients, which then resulted in an avoidance of surgery.Therefore, in carefully selected Crohn's patients, balloon dilation could be considered bene- ficial in combination with other medical treatments.

Obviously, the balloon dilation technique has been considered to be closely related to the success rate [16,20,24,27,29,30,32].We have performed maximal dilation over several days by progressive stretching of the strictured lesion.The rapidity with which the desired luminal diameter is achieved is controversial.This slow stretching schedule pro- duced a complication rate lower than other reports [30].Goldthorn and Recci have proposed that serial dilation may produce the best outcome, by progressively stretching organizing scar tissue [10,20].If the initial dilation with a small balloon was easily accomplished, the balloon siz s were gradually increased until the desired diameter was achieved.As stated in our previous study, a com- bination of TTS and OTW balloons has resulted in relatively good outcomes not only in the gastro- duodenal strictures, but also in intestinal strictures.

Factors which influence the short-and long-term results were classified according to the patient's background and morphological aspects of the stric- ture.Several factors were known to effect the out- come of the procedure; anastomotic stricture [9] early recurrence [27], having severe symptoms [27], having deep ulcerations [17], gender [17], long stricture [29,30], angulation [29], high activity [29].From our results, however, we did not find any significant risk factors other than symptomatic recurrence.

Although the length of the lesion was obviously the most important factor affecting short-term prognosis, the length was not important in respect of long-term prognosis in this study.This because recurrent inflammation at the narrowed area caused symptomat c recurrence with obstruction, fistula formation or massive hemorrhage regardless of the length of the lesion.If the activity of the disease can be controlled with appropriate medical and nutri- tional therapy, long-term prognosis will usually be more favorable.

There are a few reports that non-anastomotic strictures were effectively dilated by balloon dilation [28][29][30][31][32][33], and the efficacy of balloon dilation to non- anastomotic strictures (83%) was confirmed as well as that to anastomotic st ictures (71%), in our study.This result suggests that when the activity of the patient is low after medical and nutritional therapy, and while the stricturing site does not have deep ulceration, balloon dilation might be indicated to resolve o structive symptoms.

Less favorable results were obtained in strictures with oral luminal dilatation, which suggested that lesions with longstanding strictures might not dilate easily because of dense and thickened fibrous con- nective tissue around the strictures.

Significantly, worse results were recognized in patients with recurrent obstructive symptoms and were observed in more than half the patients who underwent dilation.As stated before, recurrence did not result from inadequate dilation technique, nor from other o vious morphological characteristics, but resulted from the natural course ofthe relapsing disease.Although more than half of the recurrent patients responded to re-dilation, we were not able to find the factors which related to the recurrence.

Recurrent patients have to be re-dilated as much as is possible.If recurrence happens again, then re-dilation in an outpatient clinic should be under- taken so long as the response to dilation is sus- tained.It is speculated that serial dilations be set up in a scheduled fashion so as to preempt symptoms of obstruction from recurring, much like the cur- rent pra