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Vascular and Interventional Radiology |
1 From the Departments of Radiology (F.C., A.E., G.S., J.V., I.B.M.) and Surgery (F.T.), Hospital General Universitario "Gregorio Marañón," Madrid, Spain. Received June 15, 1999; revision requested August 3; revision received November 23; accepted December 7. Address correspondence to F.C., Avda de Pio XII, 61, portal 8, 3° B, 28016 Madrid, Spain. (e-mail: echecamu@teleline.es).
| ABSTRACT |
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MATERIALS AND METHODS: Eighty patients with acute malignant colorectal obstruction presumed to be malignant were treated by means of implanting self-expanding metallic stents.
RESULTS: Stent placement was successful in 70 of the 80 patients and resolved bowel obstruction in 67 patients (96%). Two patients had colonic perforation and developed peritonitis 18 and 24 hours after stent placement; one patient died as a consequence. Thirty-three patients underwent elective surgery after 7 days ± 3 (SD; range, 410 days), and adequate tumoral coverage and cleansing of the colon were observed in all patients. Stent placement was used as final palliative treatment in another 35 patients. Patient follow-up lasted a mean of 138 days ± 93 (range, 36334 days). The survival rate for the palliative group was 55% at 3 months, 44% at 6 months, and 25% at 9 months. The estimated primary stent patency rate was 91% at 3 and 6 months.
CONCLUSION: Management of colorectal obstruction by using metallic stents was effective and safe, although colonic perforation is a potential complication. In cases of palliation, the method may obviate palliative colostomy.
Index terms: Colon, interventional procedures, 75.1267, 75.1299 Colon, stenosis or obstruction, 75.32 Colon neoplasms, 75.32 Interventional procedures, complications, 75.1267 Stents and prostheses, 75.1299
| INTRODUCTION |
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The use of metallic stents in the treatment of acute malignant colonic obstruction is a recent technique and a promising treatment option, although the number of reported cases is still limited. Stents have been used in most cases as decompressive therapy before surgery (410), but relatively seldom as a final palliative treatment in patients with advanced stages of the disease in whom colostomy is the only surgical option (1114). Our initial experience in seven cases of palliation was reported earlier (15).
In coordination with the emergency ward surgery unit at our institution, a program for the treatment of malignant colonic obstruction by using self-expanding metallic stents was begun in 1995. The aim of this study was to assess the feasibility, effectiveness, and safety of this technique when used as decompressive therapy, both before surgery and for palliation.
| MATERIALS AND METHODS |
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All 80 patients were examined by means of plain radiography of the abdomen and enema examination with water-soluble contrast material. Before stent placement, colonoscopy and biopsy were performed in 45 patients, and tumoral staging was performed by means of emergency computed tomography (CT) in seven. In the remaining patients, definitive diagnosis and staging were performed on an admitted or outpatient basis in the days immediately following stent placement.
The site of the obstruction was the rectosigmoid junction (n = 31), sigmoid colon (n = 41), or distal descending colon (n = 8). In 50 patients, acute obstruction was the primary manifestation of the disease, whereas 30 patients had recurrences. Informed consent was obtained from all patients or their relatives after the risks and benefits of treatment had been explained fully.
Procedure
All procedures were performed at the interventional radiology unit with fluoroscopic guidance alone. Neither analgesia nor sedation was administered during the procedure. There was no routine administration of antibiotics. With the patient in the lateral or oblique decubitus position, the procedure commenced with anal insertion of a 7-F multipurpose angiographic catheter (MPA1; Cordis Europa, Roden, the Netherlands) and a 0.038-inch angled or straight stiff-type guide wire (Glidewire; Terumo, Tokyo, Japan) until the obstruction was reached. In those patients in whom further negotiation of the catheter was blocked by dilatation or elongation of the rectosigmoid region, a stiffer 12-F introducer (Check-Flo; William Cook Europe, Bjaeverskov, Denmark) and/or a 9-F angiographic guide catheter (Cordis Europa) was used to gain access to the lesion.
After the catheter had been advanced to the lesion, water-soluble contrast material (amidotrizoate sodium and meglumine; Gastrografin, Schering España, Madrid, Spain) was injected to depict the region of the tumoral obstruction. Sometimes air was injected for that purpose. The area of the stenosis was catheterized by using the angled, stiff-type 0.038-inch hydrophilic guide wire and the multipurpose 7-F angiographic catheter. In certain patients, other types of angiographic catheters that were better suited to the morphology of the lesion were used.
Once the guide wire had been negotiated past the lesion, the catheter was advanced to the most proximal point possible, and contrast medium was injected to evaluate tumor length and exclude the possibility of perforation. The guide wire was then replaced by a superstiff 0.038-inch guide wire (Amplatz; Boston Scientific, Natick, Mass). In patients in whom exact tumor length and location were unclear, a 12-F introducer was advanced to the proximal edge of the tumor, and contrast medium was injected while keeping the superstiff guide wire in place (Fig 1). In other patients, a multipurpose 7-F catheter (MPAZ; Cordis Europa) with side holes was used for that purpose, and contrast medium was injected by using a rotating hemostatic valve (Target Therapeutics, Fremont, Calif).
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At completion of the procedure, patients were transferred to the emergency ward for observation and follow-up. Abdominal radiography was performed immediately after the procedure to ensure that the colon had not been perforated and to assess stent position. A second abdominal plain radiographic examination and enema examination with water-soluble contrast material were performed to assess stent patency and expansion and possible complications 24 hours after successful stent placement. Once the symptoms of obstruction had remitted, tumoral staging and clinical evaluation were performed in those patients in whom it had not been performed earlier to determine which patients were candidates for surgical therapy and which patients were to undergo stent implantation as the definitive palliative treatment. All patients were hospitalized for at least 48 hours after insertion of the stent. In some patients, staging was performed on an outpatient basis, at the discretion of the surgeon in charge.
Follow-up
Criteria for operability were absence of the following conditions: malignant disease in patients who were high risk, debilitated, and unsuitable for more aggressive therapy; advanced pelvic disease; peritoneal carcinomatosis; and multiple parenchymatous metastatic lesions. In all patients in whom the procedure was used as palliative therapy, examinations to assess long-term stent patency were performed during follow-up. Stent patency and patient survival rates during follow-up were calculated by using the Kaplan-Meier method. Barium enema examination was performed in all patients 1 month after discharge and whenever stent occlusion or complications were suspected. Clinical follow-up examinations by the physician in charge were scheduled at 3, 6, and 12 months. Possible stent-related complications were explained to the patients and their relatives, and they were instructed to come to the hospital whenever complications were suspected. A low-residue diet and abundant fluids were prescribed in all patients.
| RESULTS |
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Stent placement was successful in 70 of the 80 patients, a technical success rate of 88%. A total of 84 self-expanding metallic stents were implanted; one stent was deployed in 58 patients and two stents in 13 patients. None of the patients had pain during or immediately after stent placement. The mean fluoroscopy time for the procedure was 31 minutes (range, 1547 minutes).
In 67 patients (84%), the clinical and radiographic findings of bowel obstruction resolved within 24 hours after stent placement, with stent expansion and patency observable in all. Clinical failure occurred in 13 patients (16%). Symptoms of incomplete or low-grade obstruction persisted in one patient for 24 hours following the procedure. Enema examination with water-soluble contrast material revealed insufficient tumor coverage caused by partial dislodgment of the stent. This problem was resolved by deploying a second stent overlapping the first one, and the patient underwent surgery a few days later without complication. In two patients, perforation of the tumor required emergency surgery.
Complications relating to the procedure occurred in four patients. In two patients, the colon was perforated by the guide wire and catheter during maneuvering, with extravasation of contrast material into the retroperitoneum at injection. Neither of these patients experienced pain or any other symptom, hence the procedures were continued and the stents were inserted without problems in both patients. No leakage was observed at either of the enema examinations performed with water-soluble contrast material for control purposes at completion of the procedures. Antibiotic prophylaxis was administered in these two patients: 600 mg of clindamycin hydrochloride (Dalacin; Upjohn Laboratories, Madrid, Spain) administered intravenously every 8 hours and 80 mg of gentamicin sulfate (Gevramycin; Schering-Plough Laboratories, Madrid, Spain) administered intravenously every 8 hours. Both patients were observed during the days following the procedure but remained free of symptoms. At surgical intervention 5 and 7 days after the procedure, no macroscopic alterations were observed.
The other two patients developed clinical and subclinical symptoms of bowel perforation 18 and 24 hours after successful stent placement. One of the patients experienced sudden onset of severe low abdominal pain accompanied by hypotension. Emergency laparotomy revealed a perforation at the core of the obstructing tumor, and a Hartmann procedure was performed. That patient made an uneventful recovery and was discharged to his home 20 days later. The other patient complained of mild to moderate abdominal discomfort without clear evidence of abdominal tenderness or guarding. This prompted an emergency water-soluble enema examination, which demonstrated extravasation of the contrast material (Fig 2a). Immediate surgical exploration of the abdomen revealed perforation of the tumor through which the middle portion of the stent was clearly visible (Fig 2b). That patient likewise underwent a Hartmann procedure and had myocardial ischemia in the early postoperative period, which led to cardiac failure and death 28 hours later (procedure-related mortality rate, 1.3% [one of 80]).
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When we applied the criteria for operability, 33 patients were considered candidates for elective surgery; in the other 35 patients, stent implantation became the final palliative treatment.
Surgery
Thirty-three patients were considered candidates for elective surgery: those with colonic carcinoma (n = 29), diverticulitis (n = 2), or gynecologic malignancy (n = 2). The mean time between stent placement and surgery was 7 days ± 3 (SD; range, 410 days). These patients underwent preoperative bowel preparation by means of administration of polyethylene glycol according to the standard protocol used at our hospital. The stents deployed did not interfere with or prolong the surgery in any of these patients. During surgical exploration, the stents were fully expanded and in good position, and they afforded sufficient tumoral coverage and adequate cleansing of the colon in all patients. In three patients, the wires at the distal or proximal ends of the stents were observed to have caused transmural microperforation without surrounding inflammatory reaction. None of these patients had presented any symptoms in the days before surgery.
Hemicolectomy of the left side of the colon was performed in 24 patients, and low anterior resection was performed in eight. Palliative colostomy was performed in one patient subsequent to the surgical finding of widespread peritoneal carcinomatosis without possibility of anastomosis. One patient died 4 days after surgery owing to acute hepatic failure secondary to alcoholic hepatic cirrhosis. Another patient died of sepsis secondary to anastomotic breakdown on postoperative day 5. All of the remaining patients were discharged without incident.
Palliation
In 35 patients, stent placement was considered the definitive palliative treatment of colonic obstruction: colonic carcinoma (n = 23), gynecologic malignancy (n = 10), gastric carcinoma with large pelvic metastases (n = 1), or lymphoma (n = 1). In these 35 patients, 20 cases were recurrences. In six patients in this group, adjuvant chemotherapy, radiation therapy, or both were administered.
Six patients (17%) died in the 30 days following stent implantation from causes relating to their underlying disease, with no relation to the procedure or to the stent. All six patients had visceral metastases and peritoneal carcinomatosis. The stents in these patients remained patent, on the basis of lack of symptoms of colonic obstruction, until the time of death.
Follow-up in 29 patients spanned a mean time of 138 days ± 93 (range, 36334 days). The barium enema examinations performed 1 month after discharge did not reveal stent migration or any other relevant findings. The stents remained patent during follow-up in 28 patients, who remained free of symptoms of bowel obstruction.
One patient had stent occlusion 9 months after insertion and was readmitted to the hospital with symptoms of low-grade bowel obstruction. Colonoscopic results demonstrated tumoral ingrowth and overgrowth, and a second stent was implanted within the first one and alleviated the obstruction (Fig 3).
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One patient with hepatic metastases and widespread peritoneal carcinomatosis developed a rectovesical fistula secondary to radiation therapy 8 months after stent implantation. The patient underwent palliative colostomy, and at surgery the stent was shown to be patent and to be unrelated to development of the fistula, which was located distally to the stent.
Two patients had severe tenesmus related to insertion of the stents in a lower portion of the rectum. In one patient, the condition was alleviated with administration of analgesics. The other patient was readmitted twice because of persistent tenesmus despite analgesic therapy and was offered a colostomy, which ultimately was refused.
The estimated primary stent patency rate was 91% at 3, 6, and 9 months (Fig 4). The survival rate was 55% at 3 months, 44% at 6 months, and 25% at 9 months (Fig 5). The mean survival time was 147 days (range, 125169 days).
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| DISCUSSION |
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Stent placement as a therapeutic option is highly effective in achieving rapid decompression of the colon, with success rates of 80%100% (413). In our study, symptoms of obstruction were resolved in 96% (67 of 70 patients) of cases that were technically successful. The procedure produced nearly immediate relief, which permitted tumoral staging shortly after the procedure and thus better planning of definitive therapy. Colorectal carcinoma may manifest as symptoms of bowel obstruction in 8%29% of patients (3). In such patients, emergency surgery is associated with high levels of complications (4%60%), with mortality rates of up to 11% (3). Consequently, care of these patients should, ideally, endeavor to avoid emergency surgery during the acute stage of obstruction. In many cases, the use of metallic stents obviates the need for emergency surgery and colostomy.
In previously published series (4,8,9,11,13), the complication rate has been reported to range from 14% to 42%, most complications being minor. In our experience, colonic perforation was the most common complication, although often it was asymptomatic and did not require specific treatment. Colonic perforation may have different causes, related either to the method itself or to the stent. Manipulation of guide wires and catheters may result in perforation of the colonic wall. In our experience, and in that of other authors (5,8,11), perforation due to this cause has been asymptomatic, and it has been possible to complete the procedure in all cases.
Erosion of the colonic wall by the ends of the stent may be another cause of colonic perforation. This complication occurred in three patients in our study in whom microperforation without inflammatory reaction of the surrounding tissue was observed at elective surgery. None of these patients presented any symptoms in the days before surgery. Nevertheless, a case of perforation of this type that resulted in peritonitis requiring emergency surgery has been described recently (4). This type of perforation is related to the specific design of the Wallstents used in the procedure, and modification of the stent ends might prevent this complication from arising. With this exception, Wallstents would appear to be suitable for use in this type of patient, because they offer adequate radial self-expansive strength that is capable of rapidly restoring patency and resolving the obstruction. For that reason, we did not perform dilation in any of the patients either before or after stent implantation. Colonic perforation secondary to balloon dilation leading to emergency surgery has been reported (11).
To our knowledge, colonic perforation caused by expansion of the stent itself has not been described previously. This complication arose in two patients in our study in a matter of hours after insertion, probably because of a combination of the radial force exerted by the stent together with the frailty of the tumoral zone. In our study group, this was the most serious type of perforation and was followed by peritonitis in both patients in whom it occurred. On the basis of our experience, we can conclude that the possibility of colonic perforation as a potential complication must be kept constantly in mind and that consequently close clinical observation is called for, particularly in the days immediately following stent placement.
A sizeable number of patients with colorectal malignancies present with symptoms of bowel obstruction (16). Many of these patients, moreover, already have reached an advanced stage of the disease at the time of diagnosis; laparotomy results often reveal advanced tumors that are no longer resectable, widespread metastatic disease, or peritoneal carcinomatosis (16). Unfortunately, in such cases the only therapeutic options are palliative, colostomy being the only reasonable and often unavoidable surgical option.
However, this treatment option entails serious disadvantages, namely, substantial morbidity and an obvious decrease in quality of life, with major psychologic repercussions. In addition, these patients have short life expectancies, and it is therefore desirable to seek more comfortable therapeutic approaches. Such nonsurgical alternatives to colostomy as dilation (17), electrocoagulation (18), and laser photocoagulation (19) have been used in patients with unresectable tumors. In addition to highly variable results and far from negligible morbidity rates, such treatments are affected by such shortcomings as the need to be repeated periodically to maintain patency and limited applicability restricted solely to tumors in distal locations.
There has been relatively scant reporting of the use of metallic stents as a final palliative therapy, and stents have been implanted in a small number of patients with short follow-up periods; hence, assessment of stent patency and long-term behavior are difficult to define. In our experience, medium-term stent patency was high, with a mean rate of 91% at 6 months. Furthermore, stents remained patent throughout follow-up, without the need for intervention. Only one patient had stent blockage owing to tumoral ingrowth and overgrowth 9 months after insertion. On the basis of the results of our series, palliative treatment with metallic stents can be concluded to be a safe method for the medium term, provided there is close monitoring during protracted follow-up.
Stent migration is a possibility that needs to be kept in mind at all times during follow-up. In our series, there were two cases of migration and spontaneous expulsion of the stent. Stent migration has been reported previously by other authors (5,11,14) and appears to occur more often when covered stents (9) or stents with weak radial expansive strength (12) are used. We believe the cause of stent migration in the patients in our study to have been shrinkage of the tumors as a result of adjuvant chemotherapy. Consequently, specific monitoring to check for possible reduction in tumor size and assess the advisability of stent extraction is recommendable in patients receiving adjuvant therapy.
There have been reports that stents implanted in cases of low rectal tumors may cause anorectal pain and tenesmus (7,14). As was already mentioned in our preliminary report (15), two patients had this complication. Therefore, we are of the opinion that a conservative approach to stent placement is called for in the case of tumors in that location.
In conclusion, management of colorectal obstructions with metallic stents is effective and is widely applicable. In patients who are candidates for surgery, it results in good cleansing of the colon and stabilization of patients clinical conditions, allowing better planning of the final therapy. For palliation, it appears in many cases to be capable of obviating palliative colostomy. However, the possible complication of colonic perforation needs to be borne in mind, especially in the period immediately following stent placement, and therefore close clinical observation is needed.
| FOOTNOTES |
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