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Vascular and Interventional Radiology |
1 From the Department of Radiology St Joseph's Hospital and Medical Center/Barrow Neurological Institute, Phoenix, Ariz. Received December 5, 1997; revision requested February 24, 1998; revision received August 12; accepted November 5. Address reprint requests to C.L.D., Valley Radiologists Ltd, 5322 W Northern Ave, Glendale, AZ 83501.
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Abstract |
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 TOP Abstract IntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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MATERIALS AND METHODS: The authors retrospectively reviewed the charts from 643 patients referred for fluoroscopically directed percutaneous gastrostomy or gastrojejunostomy during a 9
-year period. In 615 patients, placement was attempted with use of three T-fastener gastropexy devices followed by percutaneous gastric puncture. Placement of a 14-F gastrostomy or gastrojejunostomy catheter was then accomplished with the Seldinger technique.
RESULTS: A catheter could not be placed in 28 patients (4.4%) owing to overlying viscera or prior gastric surgery. In the remaining patients, 701 procedures, including revisions, were performed, including 643 gastrojejunostomies (92%) and 58 gastrostomies (8.3%). The success rate for catheter placement was 100%. Revision was necessary in 83 instances in 64 patients (13.5%). Forty-six (55%) of these were attributed to tube dislodgment, but only two repeat gastric punctures were necessary secondary to tract disruption. There were three major complications (0.5%) and 29 minor complications (5.3%). No complications were attributed directly to gastropexy. Thirty-day follow-up data were available for 393 patients (64%), and 14-day follow-up data were available for 550 (89%). The 30-day mortality rate was 5.8% (23 of 393 patients); none of the deaths were related to the procedure.
CONCLUSION: Fluoroscopically directed percutaneous placement of gastrostomy and gastrojejunostomy catheters with routine gastropexy is a safe procedure. Catheter revision was necessary in 13% of patients and was usually secondary to tube dislodgment, with tract disruption an unusual complication.
Index terms: Gastrojejunostomy, 72.1269 • Gastrostomy, 72.1269 • Interventional procedures, complications, 72.1269 • Stomach, interventional procedure, 72.1269
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Introduction |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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Previous studies of radiologically directed enterostomy tubes have focused primarily on gastrostomy without gastropexy and on the frequency and type of associated short-term complications (8,16). More recent studies have addressed both the short- and long-term complications of gastrostomy and gastrojejunostomy without gastropexy, with the largest being a series of 478 patients (13). In our review of the literature, only one study (10) evaluated enterostomy with gastropexy in more than 300 patients.
We performed this study to evaluate the short- and long-term safety, efficacy, and cost of fluoroscopically directed percutaneous placement of gastrostomy and gastrojejunostomy catheters with routine gastropexy.
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MATERIALS AND METHODS |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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Routine preprocedural evaluation of all patients included chart review, directed physical examination, and fluoroscopic assessment of the abdomen. We believed that a catheter could not be safely placed in 28 patients (4.4%) owing to overlying viscera, high stomach position under the thoracic rib cage, or both (n = 14); uncorrected coagulopathy (n = 4); or total gastrectomy (n = 3). Two patients refused catheter placement. Early in our study, five patients with partial gastrectomy were also excluded from attempted catheter placement. With added experience, however, we no longer believe this to be a valid reason for exclusion. Overall, 701 procedures (including revision, as discussed subsequently) were attempted in 615 patients.
The technique used for percutaneous gastric puncture with gastropexy and placement of a gastrostomy or gastrojejunostomy catheter has been described previously (1,11,12,17–19). Placement was performed by either an attending interventional radiologist or a diagnostic radiology resident or fellow under appropriate supervision. Pain management was provided with local anesthesia alone in most cases or with the addition of conscious sedation if necessary. None of the patients required general anesthesia, and prophylactic antibiotics were not administered before the procedure.
Variation in specific technique and equipment used was noted during the 10-year period, but all patients underwent gastropexy, usually with three T-fastener gastropexy devices (Brown/ Mueller T-fastener set; Medi-tech/Boston Scientific, Watertown, Mass). At the completion of this study, the technique and equipment list had been standardized. Apart from the gastropexy device(s) and a 0.035-inch, 145-cm Bentson guide wire (Cook, Bloomington, Ind), all of the equipment necessary was included in a standard percutaneous gastrojejunostomy kit (Hiette Kit; Cook) and a general interventional radiology tray (General Interventional Tray; Baxter, Deerfield, Ill).
After placement of a nasogastric tube (if possible) with gastric air insufflation and the intravenous administration of 0.5–1.0 mg of glucagon (Eli Lilly, Indianapolis, Ind) for gastroparesis, gastric fixation was ensured with three gastropexy T-fasteners placed in a 2.5-cm triangular configuration. Appropriate placement was confirmed with instillation of air or ionic contrast material. An 18-gauge, 10-cm Seldinger needle was then used for gastric puncture, and pyloric catheterization was performed with a 5-F, 65-cm H1 (Cook) catheter with or without guide-wire manipulation. After cannulation of the proximal jejunum, a 0.038-inch, 180-cm Amplatz stiff guide wire (Cook) was used to maintain position, and serial dilation of the percutaneous gastric tract to 14 F was performed, followed by placement of a 14-F, 70-cm polyurethane gastrojejunostomy catheter. The pigtail retention device on the gastrojejunostomy catheter was formed in the distal stomach to assist catheter retention; no specific skin-securing devices were routinely used. Gastrostomy catheters were more frequently used early in our experience and consisted of standard placement of a 12–14-F pigtail gastrostomy catheter over a guide wire after initial gastric access. The enterostomy tube was used for medications or feeding when the output of the nasogastric tube was less than 100 mL per 8-hour period and active bowel sounds were present. The T-fastener gastropexy devices were clipped at the skin surface 10–14 days after placement.
Those patients requiring long-term gastrostomy or gastrojejunostomy catheters underwent no specific tube exchange interval early in our series and were not routinely seen unless specific indications existed. These indications included tube malfunction or dislodgment or request of the referring physician or patient. Patients who received catheters after 1992 were instructed to undergo standard catheter exchange at 6-month intervals. Replacement catheters were of a similar type and size unless pericatheter leakage was the exchange indication, and then appropriate upsizing of the catheter was used.
One investigator (C.L.D.) retrospectively reviewed the radiology reports, the procedure sheet for the procedure in question, and the patient's chart. The review included evaluation of outpatient records from our hospital and the associated clinics. Patients seen for follow-up were questioned regarding tube function and care, and all patients (or their caregivers) were instructed on tube usage and invited to contact the radiology department with any problems or questions.
Data collection criteria were defined at the study onset and included indications, initial placement success rate, complications, 30-day mortality rate, follow-up interval, number of and indications for tube revision, and time to initiation of feedings. Patients with ascites and pulmonic aspiration were also noted. Major and minor complications were defined at study onset and were taken as a representative composite of those noted in the literature, with a bias toward the clinical beliefs of our radiologists and referring clinicians. Major complications were defined as peritonitis, hemorrhage necessitating transfusion, external catheter leak necessitating catheter removal, and any other complication necessitating catheter removal (ie, severe infection, ruptured viscus, or repeat aspiration). Minor complications were defined as peritonism, superficial stomal infection, external leak requiring catheter exchange, tube malfunction requiring catheter exchange, pneumonia, and new onset of aspiration or worsening of aspiration not requiring tube removal. Dislodgment of an enterostomy tube by the patient or caregiver was not considered a complication by itself. Patients followed up for less than 14 days who did not develop a complication were excluded from the major and minor complication rates. All patients followed up for less than 1 month were excluded from the 30-day mortality rate. Current Medicare reimbursement rates were used for cost evaluation.
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RESULTS |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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Major complications arose in three patients (0.5%) (Table 1). One complication occurred in a 74-year-old man with neurologic deficits who required enteral feeding after resection of a pituitary tumor. The initial gastrostomy catheter placement was described as uneventful, but the patient subsequently developed increasing abdominal pain, fever, and an elevated white blood cell count. Output developed around the catheter and increased over several days. Although injection of iodinated contrast material through the tube performed 3 days after insertion demonstrated no leak or extravasation, the catheter was removed 2 days later and a jejunostomy tube was placed surgically. The patient recovered uneventfully from the presumed peritonitis with antibiotic therapy and was discharged to a nursing facility. No further sequelae were noted at 35-day follow-up.
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The final major complication was noted in a 65-year-old woman with metastatic ovarian carcinoma whose percutaneous gastrojejunostomy catheter had been placed with radiologic guidance 9 months earlier. She underwent standard catheter revision at the recommended 6-month interval but presented 3 months later with a completely dislodged tube. The tube was repositioned without fluoroscopic guidance in the emergency department after "probing of the gastric tract with metallic forceps." Feeding was continued, and the patient returned 12 hours later with severe abdominal pain and a white blood cell count of 28.0 x 103/µL (28.0 x 109/L). Fluoroscopic and limited CT evaluation after injection of meglumine diatrizoate into the Foley catheter (Figure) revealed an extraluminal intraperitoneal location of the Foley catheter (tip through the posterior antral wall) as well as ascites and pneumoperitoneum. Subsequent laparotomy revealed perforation of the prepyloric region of the stomach with gross peritoneal contamination and a lesser sac abscess. The patient underwent partial gastrectomy, vagotomy, and retrocolic gastrojejunostomy as well as placement of a jejunostomy feeding tube. She was discharged 11 days after admission, readmitted 3 months later with Pseudomonas pneumonia, and has had no other reported sequelae at 14-month follow-up.
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No complications, either major or minor, were attributed directly to the gastropexy device itself. Although the exact site of origin of the superficial stomal infections listed earlier was not known (gastropexy device or enterostomy site), no other clinically important sequelae were found. There were no instances of substantial gastrointestinal bleeding necessitating transfusion or complications from inadvertent puncture site (eg, hepatic or splenic puncture). Importantly, no cases of superficial stomal infection progressed to where they would have been considered major complications.
Thirty-day follow-up data were available in 393 patients (64%), and 14-day follow-up data were available in 550 (89%). The mean follow-up was 15 weeks. The overall 30-day mortality rate was 5.8% (23 of 393 patients), and there were no deaths related to the procedure.
Overall, there were 83 total revisions in 64 patients (13.5%). In addition to the 13 cases of tube malfunction and four cases of pericatheter leak necessitating catheter exchange (minor complications in Table 1), 46 tube revisions (55% of total revisions) were performed secondary to tube dislodgment. Nineteen (41%) of these occurred within 1 week of catheter insertion, and all were replaced without difficulty. The remaining procedures took place after 1 week (the presumed tract maturation period) and were replaced without other reported sequelae. Only two repeat gastric punctures were necessary secondary to tract disruption in the 83 total revisions. The first occurred approximately 7 days after initial tube insertion and was noted early in our series. The gastropexy devices were apparently still in position, but recannulation of the original gastrostomy tract was unsuccessful and a new puncture site was chosen. The other repeat gastric puncture occurred while replacing a dislodged tube approximately 2 weeks after initial catheter insertion. The gastropexy devices had been removed 10 days after placement, and the tube dislodgment was apparently forceful enough to disrupt the partially matured tract. Again, repeat puncture was accomplished without difficulty. The remaining 20 revisions were standard catheter exchanges performed for various reasons, usually by request of the referring physician or patient. These revisions included the three instances where the initial attempt at pyloric catheterization was unsuccessful, and conversion to a gastrojejunostomy was accomplished without a problem.
Time to feeding use for the catheters inserted for that indication ranged from 0 to 132 hours (mean, 21.9 hours). Feeding criteria are described in Materials and Methods.
Listed costs, unless otherwise noted, reflect current Medicare reimbursement rates in our area. Medicare Part A (technical) reimbursement for either a gastrostomy or gastrojejunostomy catheter placement is $413.31. Medicare Part B (professional) charges are $370.23 for insertion of the percutaneous gastrostomy catheter and $515.36 for insertion of a gastrojejunostomy catheter. Overall, the total current reimbursement is $783.54 for a radiologically directed percutaneous gastrostomy tube and $928.67 for a gastrojejunostomy catheter.
As for catheter exchange, standard gastrostomy or gastrojejunostomy exchange reimbursement (Part A) is $307.76 and professional charges (Part B) are $140.40, for a total of $448.16. Institutional cost for the gastropexy device (four Brown-Mueller T-fasteners) is $42.75. Additional charge for a repeat gastric puncture would reflect the additional cost of a repeat procedure. Thus, a difference in reimbursement of between $335.38 (gastrostomy) and $480.51 (gastrojejunostomy) would accompany a case where repeat puncture is required instead of a simple catheter exchange.
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DISCUSSION |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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In none of our 615 patients was ultrasonography or CT used to decide whether an enterostomy catheter should be positioned. Even so, our 4.4% rejection rate for referred patients is lower than the 7.7% rate reported in the largest nongastropexy series to date, that from Bell et al (13). In addition, although the use of oral barium and even limited barium enema may be of benefit in select patients to define colonic position, we do not agree with the routine use of these contrast agents as described by Ryan et al (10). Directed evaluation of the patient's chart, limited physical examination of the abdomen, and fluoroscopic assessment of the abdomen should reliably help eliminate essentially all problematic cases. Specifically, we agree with Hicks (19) that the colon is usually visible with fluoroscopy and that transcolonic puncture should be avoidable during percutaneous enterostomy.
The problems defining major and minor complications and the variations noted in the literature were comprehensively addressed by Ryan et al (10). Although our definitions of both major and minor complications vary slightly from those in the literature, we believe the overall comparison between our series and the other largest literature series (10,13) are valid. In fact, to our knowledge, our overall complication rates are the first reported in a large gastrostomy and gastrojejunostomy series in which those patients with limited follow-up (ie, less than 2 weeks) and no early complications were excluded from the data. This provides an important minimum time period of follow-up to ascertain that a fair complication rate has been reported.
Our categorization was otherwise designed to follow that of Bell et al (13) closely and added only one additional criterion to their major complication list—that of any other complication requiring catheter removal aside from peritonitis, hemorrhage necessitating transfusion, or external catheter leak requiring catheter removal (see Table 1). The minor complication criteria similarly followed those of Bell et al (13) and Ryan et al (10), with the following exceptions: Pneumonia or aspiration pneumonia responding well to a single course of antibiotics without repeat episodes requiring catheter removal was designated as a minor complication. Only if the pulmonary infection required catheter removal was this considered a major complication. Also, inadvertent catheter removal by the patient or a caregiver was not considered a complication by itself. If any tube malfunction was noted otherwise in this category, appropriate placement into a complication category was made.
Comparison with results of prior radiologically guided percutaneous gastrostomy or gastrojejunostomy catheter studies are detailed in Table 2, with a breakdown of those performed with and without gastropexy. Our major complication rate of 0.5% compares favorably with those reported in other series. Minor complications similarly rank in the lower range of that reported in other studies. No substantial differences—other than the overall 30-day mortality rates—were evident in the overall comparison between the gastropexy and nongastropexy series. The reason for this is unclear but is presumed to be related to the patient populations studied.
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As to the episodes of aspiration in our series, three cases of pneumonia were seen after enterostomy tube insertion; none occurred within the first 3 days. No definable evidence of aspiration was found at radiologic workup of the two patients who underwent further evaluation. No further episodes of pneumonia were found in any of the three patients, although follow-up in one patient was for less than 1 month. In addition, all patients with known aspiration received gastrojejunostomy catheters, and none showed worsening symptoms.
Sixty-four percent of the patients in our series were followed up for more than 30 days, and 89% were followed up for at least 2 weeks. Importantly, all patients deemed "complication-free" were followed up at least 14 days. Approximately two-thirds of our major and minor complications were found within 30 days of initial catheter insertion. Overall, the rate of complications after 30 days seems to be low, which supports the finding of Bell et al (13).
Revision was necessary in 13.5% of patients, a comparable rate to the larger nongastropexy studies (2,13). This was, however, much higher than that reported by Ryan et al (10), although relative comparison may be difficult as they only reported early tube dislodgments. We have found that tube dislocation is the leading cause of repeat procedures (46 of 83 procedures). All 46 cases were attributed to catheter dislodgment by patient or caregiver, and 41% of these took place within 1 week of catheter insertion. All of the early tube dislodgments were replaced without difficulty, with access gained by gently probing the established percutaneous tract. This supports one of the primary benefits of gastropexy, that of maintaining an early percutaneous tract and reducing the rate of tract disruption. The two repeat gastric punctures performed secondary to tract disruption occurred 7 and 14 days after the initial procedure. Both instances necessitating repeat puncture were likely due to a forceful or violent initial dislodgment that partially or completely disrupted the percutaneous tract. This, unfortunately, appears to be an unavoidable scenario in a small percentage of patients. Importantly, our gastropexy tract disruption rate of 2.4% (two of 83 revisions) compares favorably with that of the largest nongastropexy series (68%, 28 of 41 procedures) (13).
Further support for the routine use of gastropexy is neither clearly supported nor refuted on the basis of results of cost factor evaluation alone. Conservative estimates in our study suggest that 0.3% (two of 615) of all patients undergoing fluoroscopically guided percutaneous gastrostomy or gastrojejunostomy would require an entirely new procedure with repeat gastric puncture in 2 weeks. This compares to at least 5% and probably higher in the nongastropexy series (13), although we have found no previous studies that directly report these figures. Therefore, in a series of 300 patients, routine gastropexy would likely save at least 14 repeat procedures and, thus, the associated cost and risk. On the basis of our data, the extra cost for 14 additional procedures could be as high as $6,727.14. The current cost for routine gastropexy in these 300 patients, however, would be $12,825. The additional risk of repeat gastric puncture would parallel the major and minor complication rates described above.
As to questions of added complexity, we strongly agree with Ryan et al (10) that the technique of T-fastener gastropexy insertion is simple to master and that its use does not prolong the duration of the procedure. Including this series, the three largest on enterostomy with routine gastropexy have evaluated almost 1,000 patients and have found no added risk with gastropexy (Table 2). In fact, the complication rates appear to be comparable or slightly lower with gastropexy than without.
One additional factor supporting gastropexy is that no instances of tube migration into the peritoneal cavity were found. This lends further credence to recent findings (10) and solidifies the added safety factor that gastropexy provides in preventing this possibly disastrous complication.
In conclusion, fluoroscopically directed percutaneous placement of gastrostomy and gastrojejunostomy catheters with routine gastropexy is a safe procedure and effectively provides a route of enteric access for feeding or upper gastrointestinal tract decompression. Major and minor complication rates in our series are in the lower range of those reported in the literature, especially when compared to nongastropexy data. A primary benefit of maintaining a percutaneous gastric tract is important in a substantial number of individuals who require tube revision, and this tract is nearly always maintained with gastropexy, thus preventing the need for repeat gastric puncture. At this time, cost factors appear debatable, and further studies, preferably a randomized prospective trial, are needed.
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Footnotes |
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Author contributions: Guarantor of integrity of entire study, C.L.D.; study concepts, C.L.D., P.O.H.; study design, C.L.D., P.O.H.; definition of intellectual content, P.G.F.; literature research, C.L.D.; clinical studies, C.L.D.; data acquisition, C.L.D.; data analysis, C.L.D., L.E.S.; statistical analysis, C.L.D.; manuscript preparation, C.L.D.; manuscript editing and review, C.L.D., L.E.S., A.M.P.
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References |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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  M. H. DeLegge Enteral Access in Home Care JPEN J Parenter Enteral Nutr, January 1, 2006; 30(1_suppl): S13 - S20. [Abstract] [Full Text] [PDF]
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