Complications in Head and Neck Surgery: Pharyngocutaneous Fistula
M. Bradley Evans, M.D.
April 28, 2005

Good morning. Welcome to the V.A. Grand Rounds. Today I am going to talk about a subject that most surgeons do not like to talk about: surgical complications. Although it is somewhat taboo, complications of head and neck surgery are important to discuss, so that they may be avoided in the future. The specific complication that I would like to discuss today is one which arises following laryngeal/pharyngeal surgery: pharyngocutaneous fistula.

I would like to start out with a case report. The patient is a 55-year-old white male with a past medical history significant for hypertension and COPD, who originally presented to the DeBakey V.A. with a six-month history of hoarseness, odynophagia, and throat pain. He had previously been treated for an upper respiratory infection with antibiotics by his primary care physician, which failed to resolve his symptoms. Other review of systems was significant for minimal dysphagia. He had no history of hemoptysis, no trismus, otalgia, or any other head and neck symptoms. There was no known history of cancer in his family. He did have a 50-pack-year tobacco history and social alcohol use.

On physical examination in, he was found to have a large exophytic, ulcerative mass, which seemed to be arising from the left glottis. This extended to the anterior commissure and fixed his left hemilarynx. He had no other neck masses or lymphadenopathy palpated. CT scan of the neck confirmed a mass in the left larynx with evidence of thyroid cartilage invasion. The patient was taken to the operating room, where an examination under anesthesia and direct laryngoscopy and esophagoscopy were performed. Biopsy revealed moderately differentiated invasive squamous cell carcinoma. There were no other lesions present in the upper aerodigestive tract. He was staged as a T4N0M0 squamous cell carcinoma of the left glottis. After extensive discussion regarding his treatment, the patient was taken to the operating room, and a wide-field total laryngectomy was performed. His postoperative course was unremarkable, and he was discharged on postoperative day number 7, after tolerating a full liquid and soft diet. However, on postoperative day number 11, he represented to our clinic with increasing neck tenderness and swelling and was found to have a wound superior to his stoma that was draining what appeared to be saliva. A barium swallow, as well as methylene blue test confirmed the presence of a pharyngocutaneous fistula, so the patient was readmitted, placed on IV antibiotics, and treated conservatively with aggressive wound care, which consisted of daily debridement and twice daily packing. This fistula healed by secondary intention after 10 days of this conservative management. This was confirmed by barium swallow, and he was discharged on a soft diet. He received his postoperative radiation therapy and has no recurrence of fistula or disease on follow-up.

The objectives of today’s talk are to discuss the incidence, etiology, prevention, diagnosis, and the conservative and surgical management of pharyngocutaneous fistula.

So, what exactly is a pharyngocutaneous fistula? It is a breakdown of the mucosal closure of the pharynx, which results in salivary and secretion leakage into the surrounding soft tissues and eventual communication of the salivary tract with the skin.

What leads to a pharyngocutaneous fistula? In general, any major oropharyngeal, hypopharyngeal or laryngeal ablative tumor surgery can lead to this complication, as well as trauma to these same sites of the upper aerodigestive tract. Pharyngocutaneous fistula is the most frequent complication after total laryngectomy. It most commonly occurs within the first week to ten days. However, it has been reported as late as 42 days. If a fistula does occur this late, then the idea of a recurrent tumor should be entertained and biopsy should be performed. Pharyngocutaneous fistula is a big drain on the healthcare system and results in increased morbidity for the patient, longer hospitalizations, larger expense to the healthcare system, and even rarely mortality, which is usually due to carotid rupture.

How often does it occur? As I stated, it is the most frequent complication, and it has been shown that postoperative fistulas after major pharyngolaryngeal surgery was reported anywhere between 5 and 65 percent in the 1970s and 1980s. This incidence is decreased in the last decade, being reported anywhere between 9 and 23 percent. Case numbers range anywhere from 50 to 625 patients.

What exactly causes a pharyngocutaneous fistula? Are there any factors that we can identify preoperatively in a patient that might lead to it? Several factors have been entertained, and these can be lumped into two general categories: 1) those that are other significant comorbidities or general patient-related factors, such as poor nutritional status, diabetes, liver disease, etc. and 2) local factors, or tumor-related factors, such as the size of the tumor, the stage of the disease, pre- or postoperative radiotherapy, tracheostomy, and the extent of surgery. Starting with the first category, other comorbidities and patient-related factors, malnutrition is significant. It is especially significant in our population of head and neck cancer patients. It has been reported that approximately 35 to 50 percent of patients with head and neck cancer have clinical malnutrition, and studies have shown that a weight loss of more than 10 percent six months before surgery places head and neck cancer patients at a greater risk for any complication, including pharyngocutaneous fistula. Malnutrition has also been shown to predict poor wound healing and a general poorer prognosis in patients undergoing head and neck surgery. So, I think the key for malnutrition is that you should optimize your patients’ preoperative nutritional status, and this is very important in preventing any complication, including that which we are talking about today. Also, any systemic diseases, such as diabetes, liver disease, peripheral vascular disease, COPD, hypothyroidism, and immunosuppressive meds should be optimized prior to surgery. The key factor with this is that any metabolic disorder which will lower the immune defenses will also lengthen the wound healing time, and this must be kept in mind with these patients. This will also predispose them to postoperative complications and should be kept in mind as well.

Something that has also been studied is low postoperative hemoglobin in the preoperative period. Review of the literature, which was specific for pharyngocutaneous fistula, revealed two studies which showed a nine-fold increase in the risk of fistula in patients who had a hemoglobin level of less than 12.5 postoperatively. Another study showed an increased risk of fistula with hemoglobin of less than 11.5. Just looking at our head and neck cancer patients that we have been treating recently, these numbers actually seem pretty high. I mean, it is hardly ever that I have seen a hemoglobin level of greater than 12.5 in this population of patients. As stated, these studies were specific for pharyngocutaneous fistula, but if you look in some of the other literature, especially plastics literature, it seems that the magic number for decreasing wound complications postoperatively is a hemoglobin level of 10. Also, intraoperative transfusions have been looked at as far as increasing the risk of postoperative pharyngocutaneous fistula. In a 1993 study, the authors documented a 28% fistula rate in those patients who received at least 1 unit and in 7% of those who did not. This can kind of go along with low postoperative hemoglobin level. Whether it is the transfusion that is causing the pharyngocutaneous fistula, I kind of doubt it; it is probably multifactorial. In contrast, this study showed no correlation between intraoperative transfusions and postoperative pharyngocutaneous fistulas, as did this one. They had a higher rate, 11 percent versus 9 percent; but those numbers were not statistically significantly.

So, it is at this point that we get into a little bit of confusion regarding what the etiology is. The literature is all over the place. Some have cited that the tumor site and the stage of the disease are important in predicting the formation of a fistula. Some studies say that it is important. Others say that it is not important. Likewise, preoperative tracheostomy—some say that it is important. Some say that it is not important. And so, when trying to sift through this literature, it can actually be very confusing as to what causes a fistula and what does not predispose to a fistula. This is a perfect example with this study citing that there is no association between fistula and any of these factors, including age, gender, other comorbidity factors, T and M stage, choice of ablation, choice of reconstruction, the modality of postoperative feeding, or the choice to perform a tracheoesophageal puncture. However, this study said there is an increased risk of fistula with the extent of the surgical defect, other comorbidities, and a postoperative hemoglobin level of less than 12.5. So, when you are trying to sift through this literature, it can actually be very frustrating and can drive you crazy as to what causes a fistula. I think the point is that this is a controversial subject, and these studies are limited by the number of patients evaluated. Instead of trying to identify one or even a few factors that lead to postoperative complications, it is probably multifactorial.

One thing that is not quite so controversial is preoperative radiation therapy in leading to the development of a pharyngocutaneous fistula. As we know, radiation effects on wound healing are dose-dependent, and those that receive greater than 50 Gy of radiation tend to have more wound complications, including fibrosis. These are the things that lead to decreased wound healing: fibrosis, hypoxia, and peri-leukocyte migration.

If we look back at our ten-year literature review, you can see in those patients who received preoperative radiation therapy, the fistula rate was higher in every incidence. These numbers were not always statistically significant, but there is clearly a trend which shows that preoperative radiation is significant for the development of pharyngocutaneous fistula. Fistulas which occur in irradiated patients also may be associated with more severe secondary soft tissue damage. The fistulas may be longer in duration because of the generalized decreased wound healing properties of these patients. It has also been shown that the fistula size can be significantly larger, and appear earlier in patients with previous radiation therapy. Also, the median duration of fistula before closure can be longer in those patients who receive radiation therapy preoperatively. In this study in 1993, the authors showed that in the patients who were radiated, the median duration of fistula closure was 112 days, whereas in those that did not receive radiation was 28 days. So, as we said, the effects of radiation on surrounding soft tissue will result in a delayed wound healing response, more rapid secondary tissue effects from the fistula, and progression of the patient’s wound to advanced muscle necrosis, soft tissue necrosis, expansion of the fistula, and eventually vascular exposure if not treated promptly.

How do we prevent this potentially devastating complication from occurring? First of all, we need to recognize and identify those patients at risk preoperatively. As we stated before, any patient who has significant radiation effects of their skin and soft tissue may be considered for flap reconstruction instead of primary closure. Also, optimization of any comorbidity factors including malnutrition, diabetes, vascular disease, liver disease, and anemia should be performed.

What is the role of prophylactic antibiotics during surgery? It is the standard of care for laryngectomy, and it has been shown that prophylactic antibiotics reduce the incidence of severe wound infections by 50 percent. The organisms which should be covered include aerobic cocci. These organisms can be covered by penicillins, including ampicillin or piperacillin, or third generation cephalosporins which provide adequate coverage. Also, gastroesophageal reflux prophylaxis has been shown to be important in reducing the rate of fistula formation. In a 1995 study that specifically looked at ranitidine and metoclopramide hydrochloride given to patients one week after surgery, there was noted to be no fistulas in their small, 21-patient study group. However, there was a 26 percent fistula rate in a retrospective matched control group.

Another area of controversy is when to begin feeding patients after laryngectomy. The traditional standard is to begin feeding on postoperative day number 7 in those patients without radiation, and sometimes the feeding is delayed in patients with previous radiation therapy. However, there are those that advocate early oral feeding, including this study in 1989, which showed no difference in their fistula rate in patients fed before or after postoperative day number 5 or 6. Dr. Medina in 2001 reported only a 3.6 percent fistula rate in 55 patients that he fed within 48 hours. However, none of his patients had previous radiation therapy. In a 1990 study, no feeding tube was used in a series of 625 total laryngectomies. They were started on their feedings on postop day number 3 or 4, with a fairly low fistula rate of 9 percent compared with the reported rate. In another study, no feeding tube was used in 110 total laryngectomies. Patients were started on po feeds on postop day number 1 or 2, with a higher 21 percent fistula rate. In this study, 252 patients were fed on postoperative day number 3, and 43 patients fed after postop day number 10 with really no significant difference in their fistula rate. In a recent study in 2002, 48 patients were fed on postop day number 1, with a 12.5 percent fistula rate. So, the point of all this is that there is really no consensus on the appropriate time of initiation of oral feeding, and it is pretty much left up to the surgeon’s experience.

Another thing that should be stressed is surgical technique to decrease the risk of postoperative fistula. This includes meticulous hemostasis, atraumatic handling of mucosa, the closure type, the suture type, minimal tension on the wound, adequate use of drains, and a watertight suture line. It has been shown that Vicryl has a lower fistula rate than chromic catgut. This has been confirmed in two different studies, one in 1989 and the other in 1998. Also, as I stated, the closure type has been implicated in the formation of fistulas, although it has not been directly compared between two different techniques. Some studies have reported that the T closure is a risk factor. Minimal tension on the wound is very important as just basic surgical technique. High pharyngoesophageal pressures may contribute to fistula formation in a tight wound closure, especially the pharyngeal closure. Non-closure of the pharyngeal constrictor muscles has also been associated with a lower rate of fistula. These are all things that theoretically decrease the rate, and some people say that you should and some people say that you shouldn’t do. There is really no consistent literature on these subjects. Also, cricopharyngeal myotomy is performed in many cases to decrease the intraluminal pressure. This can also be a double-edge sword. While it does decrease the pressure and may decrease the risk of a fistula, if the wound is still closed tightly, this may be an area of dehiscence through which a fistula may form. So, regarding tight mucosal closure, this can lead to stricture or an obstruction at the distal salivary flow, and the theory is that the path of least resistance will come through the weakness in the pharyngeal suture line and into the neck instead of down into the distal esophagus and stomach. So, in these patients in which you cannot achieve mucosal closure with minimal tension, flap reconstruction should be considered. This can be accomplished with local myocutaneous flaps or free tissue transfer. There is one study which cited the routine use of pectoralis major flaps. This study in 2003 is actually kind of interesting, I thought. They retrospectively reviewed their case series of 223 total laryngectomies. Prior to 1988, they did not use pectoralis flaps routinely. However, after 1988, they routinely used pec flaps. What they found was that they dropped their fistula rate from 23 percent when not using these flaps to less than 1 percent. That is a dramatic statement, and they advocated the use of routine pectoralis flaps in these patients with total laryngectomies. However, another way to look at it, I think, is that there is a certain amount of morbidity associated with pectoralis flaps, especially when used routinely, and there are 75 percent of patients that are receiving unnecessary pec flaps.

How do we diagnose a fistula? The signs and symptoms usually become apparent 7 to 11 days after surgery. They include wound erythema, neck and facial edema with soft tissue swelling, tenderness of the neck incisions, and fever spikes. It has been shown that fevers within the first 48 hours of surgery have correlated with the development of a fistula in a review of 200 cases by Friedman in 1999. Once a fistula is formed, as it progresses, you will have contamination of the wound by saliva and dehiscence of the wound, with eventual skin flap necrosis and soft tissue necrosis if not treated promptly. This is a picture of a very large fistula that you can see actually salivary conduit in the fistula site to divert the saliva away from the neck.

Can we use barium swallows to diagnose these? Well, barium swallow routine imaging is not generally recommended before feeding in routine laryngectomies. This has been shown in a couple of studies. We do not routinely get swallow studies before feeding these patients in our practice. However, when you do suspect a fistula, it has been shown to be a reliable predictor. Especially with the sinus tract longer than 2 cm, this is predictive of fistula formation. If the drains are still in place and the drain output is increased, or even if it is stable, the drainage can be sent for a wound amylase level to predict the formation of a fistula. This test can differentiate between serous fluid and saliva in most cases.

Once we have a fistula, what can we do about it? The fundamental principles are early diagnosis, medialization of the fistulous output as protection of the great vessels is of paramount importance, along with early drainage and aggressive wound care. Failure to achieve medial pathway for fistula may lead to dissemination of saliva into the peripheral neck, elevation of the skin flaps with eventual wound breakdown, necrosis of the skin flaps, and in the worst case scenario, carotid exposure and blowout. So, it is very important that the fistula be diverted medially instead of laterally into the neck. Conservative management includes readmission of the patient, starting them on intravenous antibiotics. They should be made completely NPO. Nutritional support should be provided with an NG tube or a PEG tube, and you should also do anything necessary to optimize their response and improve their healing. Wound packing, usually with iodoform gauze is performed two to four times daily. It has been shown that most small fistulas in nonirradiated tissue will heal by secondary intention without any further management beyond this. It has been cited that they will heal anywhere between 50 and 80 percent of the time. In 2002 an article was published in the The Laryngoscope which cited that Botox injection of the salivary glands can help in the management of a fistula. The theory is that denervation of the parotid and submandibular glands will lead to a temporary reduction of salivation and allow faster healing of the fistula. Also, things that are out there – this actually has not even been published yet–is becaplermin, which is under the trade name of Regranex. It is a recombinant platelet-derived growth factor, kind of lumped under biologic response modifiers. It is a topical cream that is applied to the wound that theoretically enhances wound-healing response. It has never been studied really except for this one, and this was just a case report of two or three patients. It has never been studied in head and neck patients, but it is used a lot in patients with diabetic ulcers and peripheral vascular disease with nonhealing wounds and has been shown to work fairly well.

If conservative management does not work, what is the next step? Primary closure of the fistula has been attempted, although this is rarely possible, usually because of the minimal surrounding soft tissue loss. This should really only be attempted in very limited patients—in those that have minimal surrounding soft tissue loss, as well as healthy and adequate mucosa which can provide good closure. Even still, I do not think this works very well. Regional flaps are the mainstay of the surgical management. These include a variety of flaps, but those mainly used are the pectoralis major, latissimus dorsi, the sternocleidomastoid and trapezius flaps.

Free tissue transfer has been advocated in the closure of pharyngocutaneous fistulas. Some of the indications for a free flap would include a patient that has no remaining pharyngoesophageal mucosa and patients with circumferential defects. A free flap will introduce healthy vascularized tissue. Examples include jejunum, radial forearm, and anterolateral thigh. However, disadvantages are that the infected tissue in the neck may compromise the microvascular repair, which will increase the potential for flap failure, and then you are left with another huge problem. Also, those things which increase the risk for flap failure include scar tissue, the lack of recipient vessels in the neck, and wound healing problems, which are already present that the patient has proven just by the fact that they have a fistula. So, I think that most would agree that the pec major flap remains the workhorse for the salvage of most post-fistula neck wounds. This operation is relatively easy to perform, has a low morbidity, and has been proven time and time again.

In conclusion, pharyngocutaneous fistula remains the most frequent complication after major ablative pharyngolaryngeal surgery. Factors which delay wound healing, especially prior radiation therapy, will contribute to the increased risk of fistula formation. Optimization of patient comorbidity factors and attention to meticulous surgical technique will decrease the risk of fistula formation. Early detection and aggressive wound care are keys to successful management. Most fistulas can be managed conservatively, as we talked about, with healing by secondary intention. However, a variety of surgical options exist, including regional flaps and free flaps in persistent pharyngocutaneous fistulas.

Case Presentation:

J.L. is a 55-year-old white male with past medical history significant for hypertension and COPD, who presented to the Michael DeBakey VA Medical Center with a six-month history of progressively worsening hoarseness, odynophagia, and throat pain. Upon further evaluation, he was found to have a large exophytic, ulcerative mass arising from the left true vocal cord, which extended to the anterior commissure with fixation of the left hemilarynx. There were no other masses or lymphadenopathy palpated in the neck.

A CT scan confirmed the presence of a mass in the left larynx with evidence of thyroid cartilage invasion. Examination under anesthesia with direct laryngoscopy, esophagoscopy and biopsies was performed in the operating room, which revealed moderately differentiated squamous cell carcinoma. No other lesions were present. He was staged as a T4N0M0 SCCA of the larynx.

After extension discussion, the patient was taken to the operating room for a total laryngectomy, which was performed without difficulty. His immediate post-operative course was unremarkable, and he was discharged on post-operative day seven, after tolerating a full liquid/soft diet.

The patient presented to the Otolaryngology clinic on post-operative day 11 with increasing neck tenderness and swelling, and a newly formed wound superior to his stoma, which appeared to be draining saliva. Methylene blue test/barium swallow confirmed the presence of a fistula. The patient was readmitted, a nasogastric tube was placed, and he was treated conservatively with NPO, tube feeds, and aggressive wound care consisting of twice daily debridement and packing.

His fistula healed by secondary intention after 10 days of conservative management. He was discharged after tolerating a soft diet and completed post-operative radiation therapy as scheduled. He has no recurrence of his fistula or disease on follow-up.

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