Balloon Catheter Dilatation By A.H.
Hayashi,
J.M.
for Hypertrophic
Giacomantonio, Halifax,
Nova
0 Balloon dilating catheters (BDC) have provided a nonoperative means of managing obstructive lesions within the gastrointestinal tract. Its potential utility in infants with hypertrophic pyloric stenosis (HPS) was studied. Six patients with HPS underwent balloon catheter dilatation of the pylorus under the direct observation of the surgeon. The pylorus was exposed using a standard right upper quadrant incision. The BDC was passed transorally into the stomach and manipulated into the pyloric canal by the surgeon. The balloon was inflated with saline to a maximum pressure of 50 psi for 2 minutes. Four patients were dilated with a lo-mm diameter balloon catheter, and in two patients, a 15-mm balloon was used. Success was defined as the complete and longitudinal disruption of the seromuscular ring without violation of mucosal integrity. Using this criterion, none had successful pyloric dilatation. No disruption occurred in three patients, partial disruption in two. These patients subsequently underwent a Ramstedt pyloromyotomy. Complete disruption was observed in one: however, a breach of the mucosa was evident. This was repaired without incident. All seromuscular breaks occurred at the point of vascular entry along the lesser curve, presumably the weakest point of the ring. Pyloric dilatation using BDC does not reliably disrupt the muscular ring. This preliminary report recognizes that major refinements must occur before this method will supplant the time-honored surgical pyloromyotomy for HPS. @ 1990 by W.B. Saunders Company. INDEX
WORDS:
Hypertrophic
pyloric
stenosis.
B
ALLOON CATHETER dilatation has gained recent popularity in the therapy of obstructive lesions of the gastrointestinal tract.le4 Lesions within reach of the endoscope are potentially amenable for dilatation, which, if successful, could obviate a surgical procedure. Hypertrophic pyloric stenosis (HPS) is the most common cause of upper gastrointestinal obstruction during the late newborn and early infant period.’ Endoscopic pyloric dilatation using a balloon catheter is now a feasible consideration. Intraoperative determination of the safety and efficacy of balloon dilatation for HPS seemed warranted prior to the consideration of adopting this technique endoscopically. MATERIALS
AND
of fediatric
Surgery,
Vol 25,
Lau,
and
D.A.
Gillis
Scotia
Fig 1. Balloon catheter and saline-filled syringe.
connected
to in-line
pressure
gauge
ensuring the correct position of the catheter, the balloon was then inflated with saline. Using an in-line pressure gauge (Cook Inc, Stouffville, Ontario), a maximal pressure of 50 psi was applied for 2 minutes. The status of the pylorus was observed during this period by the operating surgeon. In one case, an intraoperative ultrasound of the pylorus during the dilatation process was obtained. After the 2-minute period, the catheter was deflated and removed. Successful dilatation was defined as the complete and longitudinal disruption of the seromuscular ring without violation of mucosal integrity. If the disruption was incomplete, a formal Ramstedt pyloromyotomy was performed along the ventral superior aspect. Unless mucosal integrity was breeched, a standard pyloric feeding schedule was instituted postoperatively. Surgical time and postoperative days of hospitalization were determined in this study group and compared with a retrospective control group of infants treated solely by pyloromyotomy. RESULTS
Using the criteria stated previously, none of the six patients studied achieved a successful result (Table I). One infant (case 6) sustained a complication directly related to the dilatation process. During balloon inflation the entire surface of the pylorus would be observed to blanch. In three cases, the seromuscular ring suddenly split, giving a distinct
METHODS
Six patientswith HPS confirmed by clinical examination, with or without radiological studies, were taken to the operating room after correction of fluid, electrolyte, and acid-base imbalances. Under general anesthesia, the pylorus was exposed using a standard right upper quadrant transverse incision. Next, a balloon dilating catheter (Fig 1) was introduced transorally into the stomach by the anesthetist and guided into the pyloric canal by the operating surgeon. A IO-mm diameter balloon (Hobbs Medical Inc, Stafford Springs, CT) was used in four patients, and in two infants, a 15-mm diameter balloon (Mansfield Scientific Inc. Mansfield, MA) was used. After hurna/
H.Y.C.
Pyloric Stenosis
No 11 (November),
1990:
pp 11 19-l
From the Department of Surgery, IWK Children’s Hospital, Halifax, Nova Scotia. Presented at the 2lst Annual Meeting of the Canadian Association of Paediatric Surgeons, Edmonton, Alberta, September 20-23, 1989. Address reprint requests to D.A. Gillis. MD. IWK Children’s Hospital, Department of Surgery, 5850 University Ave. Halifax, Nova Scotia, B3J 3G9. Canada. o 1990 by W.B. Saunders Company. 0022-3468/90/25-l I -0004$03.00/0 121
1119
1120
HAYASHI
Table
the
Age hwk)
Weight (gl
1. Results
of Pyloric
sex
BsllOOfl Diameter (mm)
Dilatation
in Six Infants Postoperative Hospitalization (d)
Result
3
1
6
4,600
M
10
2 3 4
7 6 7
3,900 5,400 5,600
F M M
10 10 10
Longitudinal Longitudinal
5 6
4 4
3,500 4,600
M M
15 15
Complete
audible “pop.” The site of the break was always found to be along the lesser curvature at the point of vascular entry. However despite this, no significant bleeding was observed. Intraoperative ultrasound performed in one such case demonstrated the effects of balloon dilatation on the seromuscular ring of the pylorus (Fig 2). In the other three cases no disruption occurred, leaving the pylorus palpably softer but completely intact. Of four patients dilated with the lo-mm balloon, a seromuscular break was produced in two. In both cases, the disruption penetrated down to submucosa, but only extended along 25% and 50% of the length of the pylorus. Of the two patients dilated with 15-mm balloon, disruption occurred in one. In this instance, the seromuscular ring was disrupted along the entire length of the pylorus but in addition, a mucosal tear was encountered. The mucosa was repaired and reinforced with an omental patch. During the procedure no changes in pulse, blood pressure, or oxygen saturations were noted. The surgi-
ET AL
muscular muscular
tear 25% tear 50%
split with mucosal
of pylorus of pylorus
disruption
2.5 2.5 2 3 4.5
cal time averaged 75 minutes compared with an average time of 45 minutes for a control group of 10 infants who had recently undergone pyloromyotomy. Despite the increased length of time under anesthesia, no added morbidity was noted postoperatively. There were no wound infections, dehisences, or respiratory complications. Significant feeding intolerance was not encountered. Postoperative days in hospital averaged 3.2 days, and was similar to the historic control group (3.4 days). DISCUSSION
Therapeutic endoscopic procedures have recently gained popularity for many conditions traditionally managed by surgical intervention. The attractive feature of successful balloon dilatation for selected gastrointestinal obstructions is that laparotomy, and potentially a general anesthetic, can be averted.6V10 When balloon dilatation was used in patients with HPS the results were extremely variable. Disruption occurred unpredictably and was not determined by
Fig 2. lntreoperative ultrasound of the pylorus (transverse view) depicting the affects of balloon dilatation. (A) Typical “donut” pattern representing the central hyperechoic mucosa surrounded by the thick hypoachoic hypertrophic muscle of the pylorus prior to dilatation. (B) After balloon dilatation. Pyloric balloon myotomy is illustrated by the loss of the donut pattern and replacement with a disorganized echo-dense acoustic pattern at the site of muscular disruption.
BALLOON
CATHETER
DILATATION
1121
FOR HPS
balloon size. All splits were found to occur along the lesser curvature and at the point of vascular entry, denoting this as the site of least resistance in the muscular ring. The unpredictable nature of these catheters and the discovery of a full-thickness disruption in one infant seriously questions the safety and utility of balloon dilatation for this disorder. We made the assumption that a complete longitudinal split of the seromuscular ring was necessary for successful therapy. Whether partial disruption or merely a stretch of the pylorus would produce functionally successful results is open to speculation and could not be addressed in this study. Several previous studies have reported good results with balloon dilatation for acquired gastric outlet obstruction secondary to fibrous strictures’9798*‘0and for functional pyloric obstruction from presumed vagal
injury.6 Successful balloon dilatation following inadequate pyloromyotomies for HPS have also been documented.6 In this instance, their good fortune may have been related to the likelihood that the segment of narrowing was short and the pylorus had already been weakened by the previous pyloromyotomy. It must be emphasized that surgical pyloromyotomy remains the treatment of choice for HPS. Its proven safety and effectiveness have remained unchallenged. Pyloric dilatation using balloon catheters does not reliably disrupt the muscular ring. This preliminary report recognizes that major refinements must occur before this method will supplant the time-honored Ramstedt procedure. ACKNOWLEDGMENT Special
thanks
to Lisa Hassell
for preparation
of this manuscript.
REFERENCES I. Benjamin SB, Glass RL, Cattau EL, et al: Preliminary experience with balloon dilation of the pylorus. Gastrointest Endosc 30:93-95, 1984 2. Graham DY, Tabibian N, Schwartz JT, et al: Evaluation of the effectiveness of through-the-scope balloons as dilators of benign and malignant gastrointestinal strictures. Gastrointest Endcsc 33:432435, 1987 3. Lindor KD, Ott BJ, Hughes RW: Balloon dilatation of upper digestive tract strictures. Gastroenterology 89:545-548, 1985 4. Siegel JH, Yatto RP: Hydrostatic balloon catheters. A new dimension of therapeutic endoscopy. Endascopy 16:231-236.1984 5. Stevenson RJ: Non-neonatal intestinal obstruction in children. Surg Clin North Am 65:1217-1234, 1985 6. Heymans HSA, Bartelsman JWFM, Herweijer TJ: Endo-
scopic balloon dilatation as treatment of gastric outlet obstruction in infancy and childhood. J Pediatr Surg 23:139-140, 1988 7. Hogan RB, Hamilton JK, Pelter DE: Preliminary experience with hydrostatic balloon dilation of gastric outlet obstruction. Gastrointest Endosc 32:71-74, 1986 8. Hogstrom H, Haglund U: A technique for endoscopic balloon dilatation of pyloric stenosis. Endoscopy 17:244-245, 1985 9. Rogers BHG: Hydrostatic dilation of upper gastrointestinal strictures with endoscopic control. Gastrointest Endosc 3 1:343-346, 1985 10. Treem WR, Long WR, Friedman D, et al: Case report. Successful management of an acquired gastric outlet obstruction with endoscopy guided balloon dilatation. J Pediatr Gastroenterol Nutr 6:992-996, 1987
Hayashi,
J.M.
for Hypertrophic
Giacomantonio, Halifax,
Nova
0 Balloon dilating catheters (BDC) have provided a nonoperative means of managing obstructive lesions within the gastrointestinal tract. Its potential utility in infants with hypertrophic pyloric stenosis (HPS) was studied. Six patients with HPS underwent balloon catheter dilatation of the pylorus under the direct observation of the surgeon. The pylorus was exposed using a standard right upper quadrant incision. The BDC was passed transorally into the stomach and manipulated into the pyloric canal by the surgeon. The balloon was inflated with saline to a maximum pressure of 50 psi for 2 minutes. Four patients were dilated with a lo-mm diameter balloon catheter, and in two patients, a 15-mm balloon was used. Success was defined as the complete and longitudinal disruption of the seromuscular ring without violation of mucosal integrity. Using this criterion, none had successful pyloric dilatation. No disruption occurred in three patients, partial disruption in two. These patients subsequently underwent a Ramstedt pyloromyotomy. Complete disruption was observed in one: however, a breach of the mucosa was evident. This was repaired without incident. All seromuscular breaks occurred at the point of vascular entry along the lesser curve, presumably the weakest point of the ring. Pyloric dilatation using BDC does not reliably disrupt the muscular ring. This preliminary report recognizes that major refinements must occur before this method will supplant the time-honored surgical pyloromyotomy for HPS. @ 1990 by W.B. Saunders Company. INDEX
WORDS:
Hypertrophic
pyloric
stenosis.
B
ALLOON CATHETER dilatation has gained recent popularity in the therapy of obstructive lesions of the gastrointestinal tract.le4 Lesions within reach of the endoscope are potentially amenable for dilatation, which, if successful, could obviate a surgical procedure. Hypertrophic pyloric stenosis (HPS) is the most common cause of upper gastrointestinal obstruction during the late newborn and early infant period.’ Endoscopic pyloric dilatation using a balloon catheter is now a feasible consideration. Intraoperative determination of the safety and efficacy of balloon dilatation for HPS seemed warranted prior to the consideration of adopting this technique endoscopically. MATERIALS
AND
of fediatric
Surgery,
Vol 25,
Lau,
and
D.A.
Gillis
Scotia
Fig 1. Balloon catheter and saline-filled syringe.
connected
to in-line
pressure
gauge
ensuring the correct position of the catheter, the balloon was then inflated with saline. Using an in-line pressure gauge (Cook Inc, Stouffville, Ontario), a maximal pressure of 50 psi was applied for 2 minutes. The status of the pylorus was observed during this period by the operating surgeon. In one case, an intraoperative ultrasound of the pylorus during the dilatation process was obtained. After the 2-minute period, the catheter was deflated and removed. Successful dilatation was defined as the complete and longitudinal disruption of the seromuscular ring without violation of mucosal integrity. If the disruption was incomplete, a formal Ramstedt pyloromyotomy was performed along the ventral superior aspect. Unless mucosal integrity was breeched, a standard pyloric feeding schedule was instituted postoperatively. Surgical time and postoperative days of hospitalization were determined in this study group and compared with a retrospective control group of infants treated solely by pyloromyotomy. RESULTS
Using the criteria stated previously, none of the six patients studied achieved a successful result (Table I). One infant (case 6) sustained a complication directly related to the dilatation process. During balloon inflation the entire surface of the pylorus would be observed to blanch. In three cases, the seromuscular ring suddenly split, giving a distinct
METHODS
Six patientswith HPS confirmed by clinical examination, with or without radiological studies, were taken to the operating room after correction of fluid, electrolyte, and acid-base imbalances. Under general anesthesia, the pylorus was exposed using a standard right upper quadrant transverse incision. Next, a balloon dilating catheter (Fig 1) was introduced transorally into the stomach by the anesthetist and guided into the pyloric canal by the operating surgeon. A IO-mm diameter balloon (Hobbs Medical Inc, Stafford Springs, CT) was used in four patients, and in two infants, a 15-mm diameter balloon (Mansfield Scientific Inc. Mansfield, MA) was used. After hurna/
H.Y.C.
Pyloric Stenosis
No 11 (November),
1990:
pp 11 19-l
From the Department of Surgery, IWK Children’s Hospital, Halifax, Nova Scotia. Presented at the 2lst Annual Meeting of the Canadian Association of Paediatric Surgeons, Edmonton, Alberta, September 20-23, 1989. Address reprint requests to D.A. Gillis. MD. IWK Children’s Hospital, Department of Surgery, 5850 University Ave. Halifax, Nova Scotia, B3J 3G9. Canada. o 1990 by W.B. Saunders Company. 0022-3468/90/25-l I -0004$03.00/0 121
1119
1120
HAYASHI
Table
the
Age hwk)
Weight (gl
1. Results
of Pyloric
sex
BsllOOfl Diameter (mm)
Dilatation
in Six Infants Postoperative Hospitalization (d)
Result
3
1
6
4,600
M
10
2 3 4
7 6 7
3,900 5,400 5,600
F M M
10 10 10
Longitudinal Longitudinal
5 6
4 4
3,500 4,600
M M
15 15
Complete
audible “pop.” The site of the break was always found to be along the lesser curvature at the point of vascular entry. However despite this, no significant bleeding was observed. Intraoperative ultrasound performed in one such case demonstrated the effects of balloon dilatation on the seromuscular ring of the pylorus (Fig 2). In the other three cases no disruption occurred, leaving the pylorus palpably softer but completely intact. Of four patients dilated with the lo-mm balloon, a seromuscular break was produced in two. In both cases, the disruption penetrated down to submucosa, but only extended along 25% and 50% of the length of the pylorus. Of the two patients dilated with 15-mm balloon, disruption occurred in one. In this instance, the seromuscular ring was disrupted along the entire length of the pylorus but in addition, a mucosal tear was encountered. The mucosa was repaired and reinforced with an omental patch. During the procedure no changes in pulse, blood pressure, or oxygen saturations were noted. The surgi-
ET AL
muscular muscular
tear 25% tear 50%
split with mucosal
of pylorus of pylorus
disruption
2.5 2.5 2 3 4.5
cal time averaged 75 minutes compared with an average time of 45 minutes for a control group of 10 infants who had recently undergone pyloromyotomy. Despite the increased length of time under anesthesia, no added morbidity was noted postoperatively. There were no wound infections, dehisences, or respiratory complications. Significant feeding intolerance was not encountered. Postoperative days in hospital averaged 3.2 days, and was similar to the historic control group (3.4 days). DISCUSSION
Therapeutic endoscopic procedures have recently gained popularity for many conditions traditionally managed by surgical intervention. The attractive feature of successful balloon dilatation for selected gastrointestinal obstructions is that laparotomy, and potentially a general anesthetic, can be averted.6V10 When balloon dilatation was used in patients with HPS the results were extremely variable. Disruption occurred unpredictably and was not determined by
Fig 2. lntreoperative ultrasound of the pylorus (transverse view) depicting the affects of balloon dilatation. (A) Typical “donut” pattern representing the central hyperechoic mucosa surrounded by the thick hypoachoic hypertrophic muscle of the pylorus prior to dilatation. (B) After balloon dilatation. Pyloric balloon myotomy is illustrated by the loss of the donut pattern and replacement with a disorganized echo-dense acoustic pattern at the site of muscular disruption.
BALLOON
CATHETER
DILATATION
1121
FOR HPS
balloon size. All splits were found to occur along the lesser curvature and at the point of vascular entry, denoting this as the site of least resistance in the muscular ring. The unpredictable nature of these catheters and the discovery of a full-thickness disruption in one infant seriously questions the safety and utility of balloon dilatation for this disorder. We made the assumption that a complete longitudinal split of the seromuscular ring was necessary for successful therapy. Whether partial disruption or merely a stretch of the pylorus would produce functionally successful results is open to speculation and could not be addressed in this study. Several previous studies have reported good results with balloon dilatation for acquired gastric outlet obstruction secondary to fibrous strictures’9798*‘0and for functional pyloric obstruction from presumed vagal
injury.6 Successful balloon dilatation following inadequate pyloromyotomies for HPS have also been documented.6 In this instance, their good fortune may have been related to the likelihood that the segment of narrowing was short and the pylorus had already been weakened by the previous pyloromyotomy. It must be emphasized that surgical pyloromyotomy remains the treatment of choice for HPS. Its proven safety and effectiveness have remained unchallenged. Pyloric dilatation using balloon catheters does not reliably disrupt the muscular ring. This preliminary report recognizes that major refinements must occur before this method will supplant the time-honored Ramstedt procedure. ACKNOWLEDGMENT Special
thanks
to Lisa Hassell
for preparation
of this manuscript.
REFERENCES I. Benjamin SB, Glass RL, Cattau EL, et al: Preliminary experience with balloon dilation of the pylorus. Gastrointest Endosc 30:93-95, 1984 2. Graham DY, Tabibian N, Schwartz JT, et al: Evaluation of the effectiveness of through-the-scope balloons as dilators of benign and malignant gastrointestinal strictures. Gastrointest Endcsc 33:432435, 1987 3. Lindor KD, Ott BJ, Hughes RW: Balloon dilatation of upper digestive tract strictures. Gastroenterology 89:545-548, 1985 4. Siegel JH, Yatto RP: Hydrostatic balloon catheters. A new dimension of therapeutic endoscopy. Endascopy 16:231-236.1984 5. Stevenson RJ: Non-neonatal intestinal obstruction in children. Surg Clin North Am 65:1217-1234, 1985 6. Heymans HSA, Bartelsman JWFM, Herweijer TJ: Endo-
scopic balloon dilatation as treatment of gastric outlet obstruction in infancy and childhood. J Pediatr Surg 23:139-140, 1988 7. Hogan RB, Hamilton JK, Pelter DE: Preliminary experience with hydrostatic balloon dilation of gastric outlet obstruction. Gastrointest Endosc 32:71-74, 1986 8. Hogstrom H, Haglund U: A technique for endoscopic balloon dilatation of pyloric stenosis. Endoscopy 17:244-245, 1985 9. Rogers BHG: Hydrostatic dilation of upper gastrointestinal strictures with endoscopic control. Gastrointest Endosc 3 1:343-346, 1985 10. Treem WR, Long WR, Friedman D, et al: Case report. Successful management of an acquired gastric outlet obstruction with endoscopy guided balloon dilatation. J Pediatr Gastroenterol Nutr 6:992-996, 1987
