Incidence and Outcome of Biliary Strictures After Pancreaticoduodenectomy

Abstract

Objective:

This single-institution review examined the incidence of biliary stricture formation after pancreaticoduodenectomy (PD) for benign and malignant periampullary disease.

Background:

The incidence and course of stricture of the hepaticojejunostomy have not been documented after PD.

Methods:

Between January 1995 and April 2003, 1595 patients underwent PD for periampullary disease (392 benign, 1203 malignant). A retrospective analysis of a prospectively collected database was performed to determine the incidence of biliary stricture after PD.

Results:

Forty-two of the 1595 patients (2.6%) who underwent PD developed postoperative jaundice secondary to a stricture of the biliary-enteric anastomosis. There was no difference in the incidence of biliary strictures after resection for benign (n = 10, 2.6%) or malignant disease (n = 32, 2.6%). The median time to stricture formation resulting in jaundice was 13 months (range, 1–106 months) and was similar for patients with benign and malignant disease. Preoperative jaundice did not protect against biliary stricture formation. By univariate analysis, biliary strictures were associated with preoperative percutaneous biliary drainage (odds ratio [OR] = 2.11, P = 0.02) and postoperative biliary stenting (OR = 2.11, P = 0.013). Postoperative chemoradiotherapy in patients with malignant disease was not associated with stricture formation. All strictures were initially managed with percutaneous biliary balloon dilatation and stenting, and only 2 patients required redo hepaticojejunostomy. Recurrent neoplastic disease was discovered in only 3 of the 32 patients (9%) with malignant disease. All 3 of these patients had cholangiocarcinoma as their initial diagnosis.

Conclusions:

Biliary stricture formation is an infrequent complication after PD and can be managed successfully with percutaneous biliary dilatation and short-term stenting in most patients. The only significant univariate predictors for biliary stricture formation were preoperative and postoperative percutaneous biliary drainage. The development of a biliary stricture in patients who have undergone PD for malignant disease is usually benign and should not be automatically attributed to anastomotic tumor recurrence.

Biliary strictures are infrequent (2.6%) after pancreaticoduodenectomy. They occur equally in patients with benign and malignant disease, and can be managed successfully with percutaneous biliary dilatation and short-term stenting. Using multivariate analysis, no predictors of post-Whipple biliary stricture formation were found.

Advances in operative technique and postoperative care have resulted in a decrease in the substantial mortality that was once associated with pancreaticoduodenectomy. However, despite the many improvements in clinical management of patients undergoing pancreaticoduodenectomy, postoperative complications remain frequent.^1–4 Reports from large-volume pancreatic surgery centers have focused mainly on the early postoperative complications after pancreaticoduodenectomy, such as delayed gastric emptying, pancreaticocutaneous fistula, and surgical site infection.1,2,5,6 Few studies have examined the postoperative complications that present after hospital discharge.⁷ The purposes of this retrospective study were to determine the late incidence of biliary stricture formation after pancreaticoduodenectomy for benign and malignant diseases, to determine the etiology and risk factors for stricture formation, and to review our clinical experience with managing this complication.

METHODS

Patient Selection

Over a 100-month interval from January 1995 to April 2003 inclusive, a total of 1595 patients underwent pancreaticoduodenectomy at the Johns Hopkins Hospital. For all of these patients, clinical follow-up was available. The median follow-up was 27 months (range, 1–119 months). After permission from the Johns Hopkins University Joint Committee on Clinical Investigation, information regarding patient characteristics, preoperative workup, operative technique, surgical specimen features, and clinical follow-up was collected retrospectively from a prospective pancreaticoduodenectomy database combined with the hospital's electronic patient record system. Patients who developed obstructive jaundice after discharge from the hospital after pancreaticoduodenectomy were identified from the database. A postoperative biliary stricture was defined as a radiologically proved focal stricture at the level of the choledocho- or hepaticojejunostomy in the setting of obstructive jaundice.

Patient Management

Standard preoperative management, operative technique for pancreaticoduodenectomy, and post-pancreaticoduodenectomy patient management at our institution have been published previously.² After pancreaticoduodenectomy, reconstruction included an interrupted single-layer biliary enteric anastomosis with either mono- or polyfilament absorbable 4–0 or 5–0 suture material. A closed suction drain was positioned near the biliary anastomosis. For patients who underwent preoperative percutaneous transhepatic biliary drainage, the catheter was left in place postoperatively to decompress the biliary anastomosis, usually for a 6-week period. Some of the remaining patients were reconstructed with a T-tube to decompress the biliary anastomosis; however, the majority of patients were not stented.

All postoperative biliary strictures were evaluated by interventional radiology with percutaneous transhepatic cholangiography (PTC) and managed with the placement of a biliary catheter (PBD) across the stricture. Balloon dilatation was carried out initially, and the anastomosis was stented for varying periods. For patients with biliary strictures who had undergone pancreaticoduodenectomy for malignant disease, cytobrushings and clam shell biopsies of the biliary enteric anastomosis were performed at the time of PTC.

Statistical Analyses

Statistical data were analyzed and computed with Stata Release 6 (College Station, TX) software. χ² tests were performed for univariate analyses of categorical values. Mean values, presented when appropriate with ± SEM, were compared by the Student t test. Logistic regression was performed for multivariate models with P values and 95% confidence intervals estimated by the Wald method. Statistical significance was defined as P value of <0.05.

RESULTS

Biliary Strictures After Pancreaticoduodenectomy

Of the 1595 patients who underwent pancreaticoduodenectomy between January 1995 and April 2003, 1203 patients (75.5%) had a malignant neoplasm. The remaining 392 patients were found to have benign disease on final histopathologic examination of their surgical specimens. Overall, 42 patients (2.6%) developed postoperative biliary strictures after pancreaticoduodenectomy (Table 1). Among patients with cancer, 32 (2.6%) developed a biliary stricture. The incidence of biliary stricture formation in patients with benign disease was 2.6% (10 of 392 patients). The median time to biliary stricture formation after pancreaticoduodenectomy was 13 months. Strictures were detected as early as 1 month after pancreaticoduodenectomy and as late as 9 years after pancreaticoduodenectomy. There was no difference in the time to stricture formation for the malignant and benign groups.

TABLE 1. Biliary Strictures After Pancreaticoduodenectomy

Risk Factors for Biliary Strictures

Risk factors for biliary stricture formation after pancreaticoduodenectomy were conceptually divided into 3 broad categories: patient-related factors, disease-related factors, and procedure-related factors. The patient-related factors that were analyzed as univariate predictors for stricture formation included age, gender, race, and the presence of comorbidities (Table 2). Age, gender, race, and medical comorbidities, including diabetes mellitus, smoking, chronic pancreatitis, and coronary artery disease, did not predict biliary stricture formation after pancreaticoduodenectomy.

TABLE 2. Patient- and Disease-Related Risk Factors for Biliary Stricture Formation

Univariate analysis of disease-related factors are also summarized in Table 2. Neither benign nor malignant disease influenced biliary stricture formation after pancreaticoduodenectomy. Among the 32 patients who had undergone pancreaticoduodenectomy for a malignant neoplasm and later developed a biliary stricture, 8 patients (25% of the malignant group) had undergone pancreaticoduodenectomy for a primary cholangiocarcinoma. Only 13% of the patients who did not develop a stricture after pancreaticoduodenectomy carried a diagnosis of cholangiocarcinoma. This difference approached but did not reach statistical significance. All of the 8 patients with cholangiocarcinoma had undergone pancreaticoduodenectomy with a negative bile duct margin. At the time of stricture evaluation with PTC and biopsy, 3 of these 8 patients were found to have recurrent neoplastic disease involving the biliary enteric anastomosis. Strictures as a result of recurrent cholangiocarcinoma at the biliary enteric anastomosis presented between 7 and 29 months after pancreaticoduodenectomy.

Patients who presented initially with obstructive jaundice prior to pancreaticoduodenectomy had a similar incidence of stricture formation compared with patients who did not present with jaundice prior to pancreaticoduodenectomy. Of the 828 patients who presented with jaundice prior to pancreaticoduodenectomy, 27 (3.3%) later developed a postoperative biliary stricture. Preoperative jaundice was present in 64% and 52% of the patients who did or did not develop a postoperative stricture, respectively. This difference was not significant.

Analysis of procedure-related risk factors for postoperative biliary stricture formation after pancreaticoduodenectomy are summarized in Table 3. Two basic surrogate indicators for operative complexity, namely, estimated blood loss and operative time, did not correlate with biliary stricture development. The type of pancreaticoduodenectomy did not affect the incidence of postoperative biliary strictures. The presence of a pancreaticojejunostomy near the bile duct anastomosis along the afferent limb was also not associated with stricture formation as evidenced by the similar incidence of strictures in patients who underwent total pancreatectomy. Differences in the use of preoperative biliary drainage, either with endobiliary prostheses or PBD, did affect rates of postoperative biliary strictures. Preoperative PBD was a significant risk factor for stricture formation; whereas, biliary endostenting had a protective effect. Postoperative biliary drainage with a T-tube did not affect stricture rate; however, continuation of a preoperative PBD after pancreaticoduodenectomy was associated with biliary stricture formation. The development of a pancreaticojejunostomy leak and pancreaticocutaneous fistula did not correlate with biliary stricture formation nor did the administration of postoperative chemoradiotherapy. Postoperative bile leaks from the choledocho- or hepaticojejunostomy also did not predispose to biliary stricture formation. Among the 42 patients who developed a biliary stricture, only 2 (5%) had a documented bile leak after pancreaticoduodenectomy.

TABLE 3. Procedure-Related Risk Factors for Biliary Stricture Formation

To exclude the possibility of covariance among the predictors of postoperative biliary strictures after pancreaticoduodenectomy, we examined a multivariate model incorporating the 4 predictors with the highest odds ratios, preoperative and postoperative PBD, distal cholangiocarcinoma, and postoperative chemoradiotherapy (Table 4). We included the last 2 factors even though they did not reach statistical significance on univariate analysis. In this multivariate model, none of these factors was an independent predictor of a postoperative biliary stricture.

TABLE 4. Multivariate Model to Predict Biliary Stricture Formation

Management of Biliary Strictures

All of the 42 patients with biliary strictures in this series were evaluated and managed initially with PTC and PBD. Eighty-eight percent of patients overall and 90% of patients with benign disease were managed successfully with PBD, balloon cholangioplasty, and stenting with a silastic stent exclusively (Fig. 1). During the workup for a biliary stricture, 3 patients in the malignant group were found to have recurrent disease involving the bile duct anastomosis and underwent placement of a percutaneous biliary wallstent. All of these patients had undergone pancreaticoduodenectomy for a cholangiocarcinoma. Two patients, one who had undergone pancreaticoduodenectomy for benign and one for malignant disease, failed management with PBD and serial balloon dilations of their biliary strictures, and eventually required operative revision of their bile duct anastomoses.

FIGURE 1. PTC demonstrating a tight anastomotic stricture involving the hepaticojejunostomy approximately 1 year after pancreaticoduodenectomy for pancreatic cancer (A). Technique of balloon cholangioplasty across the hepaticojejunostomy stricture (B). Decompressed biliary system after successful balloon dilatation of the anastomotic stricture (C).

Successful management of postoperative biliary strictures required an average of 7.5 PBD exchanges, upsizings, and/or balloon dilatations, including the initial PTC/PBD (Table 5). Patients with benign disease required more interventions than those with malignant neoplasms, 11.7 versus 6.25. The median duration of PBD with a silastic stent after stricture detection was 5.5 months and did not differ significantly for patients with benign or malignant primary disease. The majority of patients with biliary strictures were managed on an outpatient basis. On average, only one hospital admission was required to manage a biliary stricture in this series. To date, no patients have redeveloped biliary strictures after successful cholangioplasty.

TABLE 5. Management and Outcomes of Biliary Strictures

The outcomes of patients who developed biliary strictures after pancreaticoduodenectomy for malignant neoplasms are summarized in Table 6. Routine brush and clam shell biopsies were obtained during the initial PTC and PBD of all biliary strictures in the malignant group. Recurrent malignant disease was detected in only 3 of the 32 patients with malignancies. All 3 of the malignant recurrences occurred in patients with distal cholangiocarcinoma. Patients with anastomotic recurrences were managed successfully with biliary wallstents. The median survival for patients with periampullary cancer who developed postoperative biliary strictures was 19.5 months after pancreaticoduodenectomy. After stricture detection, the median survival was 8 months. For the 3 patients with recurrent malignant disease involving the hepaticojejunostomy, the median survival was 3 months after stricture detection.

TABLE 6. Outcomes of Biliary Strictures Within Malignant Group

DISCUSSION

In recent years, increasing clinical experience with pancreaticoduodenectomy has led to a substantial drop in hospital mortality; however, postoperative morbidity has remained in the 30% to 40% range, with delayed gastric emptying and pancreaticocutaneous fistula being the most common complications.^1,2–9 As experience with pancreaticoduodenectomy has increased at high-volume centers, other less common postoperative complications have been recognized. One of these complications is the development of a biliary stricture months following pancreaticoduodenectomy. During a 100-month period between 1995 and 2003, 42 (2.6%) of 1595 patients at the Johns Hopkins Hospital developed a postpancreaticoduodenectomy stricture at the biliary enteric anastomosis. There was no difference in biliary stricture incidence between patients with benign or malignant disease. Patients who developed a postoperative biliary stricture presented, on average, 13 months after pancreaticoduodenectomy, and this was the same for benign and malignant primary disease. The earliest stricture occurred at 1 month postpancreaticoduodenectomy and the latest at nearly 9 years. Examination of the potential risk factors for the development of a bile duct stricture after pancreaticoduodenectomy focused on the patient, the disease, and the operative procedure. Bile duct ischemia has been suggested as a cause of stricture formation; therefore, patient comorbidities that might compromise visceral perfusion were considered as risk factors.^10,11 Age, diabetes, smoking, chronic pancreatitis, and coronary artery disease were not associated with postoperative anastomotic strictures.

Preoperative jaundice, which was assumed to be a surrogate for biliary dilatation, was present in 64% of patients who later developed a biliary stricture. One might assume that a large bile duct would make a subsequent biliary stricture after pancreaticoduodenectomy unlikely; however, ductal dilatation was not protective against stricture formation.

The incidence of postpancreaticoduodenectomy biliary strictures was the same for patients with benign or malignant disease. Patients with distal cholangiocarcinoma were at higher (albeit statistically not significant) risk for stricture formation compared with other periampullary cancers or benign disease. Of the 32 patients who underwent pancreaticoduodenectomy for malignant disease and later developed a postoperative biliary stricture, 8 had cholangiocarcinoma. A negative bile duct margin was achieved during pancreaticoduodenectomy in all 8 of these patients. However, all 3 of the anastomotic recurrences in the malignant group of patients with biliary strictures involved cholangiocarcinoma. The median time to stricture formation in these 3 patients with recurrent malignant disease involving the biliary enteric anastomosis was 27 months. For patients who had undergone pancreaticoduodenectomy for cholangiocarcinoma and developed a biliary stricture but did not have evidence of recurrent disease, the median time to stricture formation was 14 months.

Leaks involving the bilioenteric anastomosis are uncommon after pancreaticoduodenectomy and occur in less than 3% of patients at our institution.^2,9 Intuitively, postoperative bile leaks should be considered a risk factor for later biliary stricture formation; however, a postoperative bile leak did not prove to be a risk factor for the development of a delayed postoperative biliary stricture. Likewise, the development of a postoperative pancreaticocutaneous fistula did not correlate with biliary stricture formation.

With univariate analysis, preoperative biliary endostenting afforded a protective effect against postoperative biliary stricture formation, whereas the use of preoperative PBD was a significant univariate risk factor for stricture formation. These findings are difficult to correlate. PBD can lead to increased inflammation and fibrosis, which could predispose to postoperative stricture formation. Why the opposite was true for biliary endostenting is unclear. The continuation of preoperative PBD during the postoperative period was also associated with biliary stricture formation. However, with multivariate analysis, there were no significant risk factors.

All of the 42 postoperative biliary strictures in this series were evaluated and managed initially with PTC and PBD. Nearly 90% of all patients were managed successfully with PBD and balloon cholangioplasty alone. Two patients required redo hepaticojejunostomy after failure of repeated percutaneous dilatations. The 3 patients with malignant anastomotic recurrences of cholangiocarcinoma were managed with biliary wallstents.

Endoscopic or percutaneous biliary biopsy, either with cytobrushing or clam shell, was used in an effort to detect recurrent malignant disease as a cause for postoperative biliary strictures.^15,16 Only 3 of the 32 (9%) patients with malignant disease who developed a postoperative stricture were found to have recurrent disease involving the bile duct anastomosis. These patients were managed successfully with placement of a PBD-directed biliary wallstent.¹⁷

Biliary stricture formation is an uncommon late complication after pancreaticoduodenectomy and should not be automatically attributed to recurrent disease in patients with resected periampullary cancer. Its incidence is identical in benign and malignant disease. Likewise, the time to biliary stricture formation after pancreaticoduodenectomy is identical for benign and malignant disease. Despite a large experience with pancreaticoduodenectomy, we have not been able to elucidate risk factors predisposing to biliary stricture formation.

Discussions

Dr. Andrew L. Warshaw (Boston, Massachusetts): My first observation, like Dr. Cameron's, is that it is amazing that there was such a low incidence of biliary stricture, occurred, but isn't it also amazing that the rate of occurrence is the same in bile ducts that are thickened and dilated as in those that are thinned and non-dilated?

One of my questions is as follows: You looked for a common causality for each group, but maybe you are missing the cause because they are different for each group.

You considered ischemia of the bile duct, but the factors you looked at did not include what you did to the bile duct during the operation. It is the norm that the cut end of the bile duct bleeds profusely from marginal vessels. It must be very rare that the end of the bile duct used for the anastomosis starts ischemic. But many surgeons put a bulldog or vascular clamp on the bile duct to control the bile leaking during the course of the operation. I wonder if the clamping could possibly be a cause of injury and ischemia. If, on the other hand, there are different causes with the two groups, maybe the small ducts that become strictured are those that do so because it is more difficult to maintain patency of a small duct whereas those that are obstructed and dilated are more likely to be stented preoperatively and develop infection. Those ducts are also more exposed to trauma from the stent, and a percutaneous stent, if left in for a long time postoperatively, might add to the injury.

One other question relates to those patients who get radiated and then require a stricture repair. Are there additional surgical difficulties or postoperative complications in patients who have been radiated? If the stricture occurs late, after radiation-induced ischemia has evolved, are you more reluctant to undertake a surgical revision?

Dr. Michael G. House (Baltimore, Maryland): With a database of 1600 patients, the precise technical detail of each hepaticojejunostomy was not available for complete review. Trends between surgeons at the Johns Hopkins Hospital do exist. Some routinely clamp the hepatic duct or the common bile duct prior to hepaticojejunostomy or choledochal jejunostomy, respectively, whereas others do not clamp the bile duct prior to reconstruction. There was no difference in the incidence of biliary stricture between surgeons who do or do not clamp bile ducts during the Whipple procedure.

Does a dilated bile duct preoperatively protect against a postoperative stricture? In this study, we used preoperative jaundice as a surrogate marker for a dilated extrahepatic biliary tree and found that preoperative jaundice was not a significant factor protecting against stricture formation. Our aggressive use of preoperative biliary drainage may be deleterious toward the protective effect of having a dilated bile duct.

More than 90% of the patients who presented with a biliary stricture after a Whipple procedure were managed successfully with percutaneous cholangioplasty after initial biliary drainage.

On average, patients required 6 months of percutaneous biliary drainage to manage a biliary stricture. For the 2 patients who required re-do hepaticojejunostomy, one was a patient with benign disease and the other had malignant disease.

Dr. R. Scott Jones (Charlottesville, Virginia): I would like to make a couple of comments and elaborate on issues.

I think one factor that may play a role in the stricture matter is whether the stricture is in the duct, the pathology is in the duct, or it is at the anastomosis. I think that makes a difference. The Hopkins group told us in a study of biliary strictures some years ago that those strictures at an anastomosis like a hepaticojejunostomy and no other pathology are most amenable to balloon dilatation. And we have followed that principle and found that to be true, that if we are talking about an anastomotic stricture, those are extremely well managed usually with a single intervention with balloon dilatation, in contrast to those situations in which there is pathology in the duct.

Another important point in this paper that I would like to follow up on is the issue of preoperative stenting with a percutaneous transhepatic tube. We now have this firm evidence with statistical parameters that that practice increases the likelihood for the development of a long-term biliary stricture. That is one thing I think we need consider during the preoperative evaluation.

It is my belief that most of this pre-insertion of stents in patients who are candidates for Whipple, much of that practice is unnecessary. Most of those patients are not debilitated. Most of those patients today could be operated on sooner rather than later, and I think the addition of the transhepatic manipulation simply increases the delay and has a morbidity and mortality in its own right. And I think Dr. Cameron and his colleagues have provided further evidence that we can now take that back to our colleagues who manage these patients and ask them to abandon these practices or do it more thoughtfully.

One additional comment, if I may. For the last two decades, members of the Southern Surgical Association have been benefited annually with an array of outstanding results of clinical research from the Johns Hopkins Hospital. This is just another example. They have influenced the care of patients with hepatobiliary disease all over the world. And I think we need to recognize that and express our appreciation.

My opinion about this is that the work from this group represents a metaphor. If you think about it for a moment, they have examined processes of care, done their best to implement best practices. They have done this with guidelines and protocols. They have maintained outcomes with a splendid, disciplined outcome registry, which enables this kind of work to surface in meetings such as this. In addition, they have been active participants in the clinical trial endeavors.

Now, those are the things that drive improving quality of surgical care. And I think that we need to take their lead, listen to their message, and marshal the resources that are available to move this practice into every hospital in the United States. These principles of surgical quality improvement that they have been doing for more than two decades are just as applicable in your hospital as they are at the Johns Hopkins Hospital. And I think we need to work together to hear this message and to spread it.

Dr. Michael G. House (Baltimore, Maryland): The radiographic features of the 42 postoperative biliary strictures were similar in the benign and malignant groups and were consistent with an abrupt cutoff at the level of the biliary-enteric anastomosis. Long, tapered strictures over several centimeters of bile duct were not observed.

The median survival of patients after stricture detection was 8 months in the malignant group of patients. This median survival argues against the presence of occult recurrent disease involving the biliary-enteric anastomosis.

The use of preoperative stenting may be a true risk factor for biliary stricture formation or a bystander factor resulting from the use of a percutaneous biliary drain in the postoperative setting.

Dr. Bryan M. Clary (Durham, North Carolina): In my short career in doing this operation, the only time I have really seen this is in people who have malignancy. Your comment that the median survival post-identification of the stricture likely argues against it, I am not quite so sure. I was wondering if you looked at the pattern of disease recurrence at the time of death in this patient population; meaning, did they ultimately have locoregional recurrence when they died?

A second question. Over this time period, typically drainage is done endoscopically and ERCPs are widely available since the era of 1995. And typically PVDs percutaneous biliary drains are placed in people in whom ERCPs have been unsuccessfully. So I was wondering, if you look at these patients, were they patients in whom multiple ERCPs were attempted and did they have cholangitis as compared to the patients who were successfully stented endoscopically?

Dr. Michael G. House (Baltimore, Maryland): Your question is directed towards the pattern of recurrences in patients with malignant disease who later developed a biliary stricture after Whipple. We have follow-up for about 80% of the patients in this study and have observed that the majority of patients who develop recurrent disease die of systemic metastases, not of locoregional spread. An 8-month median survival after developing a biliary stricture supports our finding that the majority of these strictures were benign and that we didn't miss recurrent disease at the biliary-enteric anastomosis.

A large number of patients underwent percutaneous biliary drainage, which probably doesn't reflect the practices of most centers. Endo-biliary stenting was attempted in almost all these patients prior to being referred for transhepatic biliary drainage.

Dr. Steven M. Steinberg (Columbus, Ohio): Did you look at where in the bile duct the anastomosis was made? Was it in the common bile duct or the common hepatic duct? Did the site of anastomosis correlate with the development of stricture with the thought that maybe more distal anastomoses would be more ischemic?

Secondly, did you look to see if there is a relationship between the presence of microorganisms in the bile at the time of surgery and whether there is any relationship between that finding and the occurrence of stricture?

Dr. Michael G. House (Baltimore, Maryland): Could fibrosis of the bile duct be associated with percutaneous biliary drainage? Undoubtedly, recurrent episodes of cholangitis during the preoperative and postoperative settings may predispose patients for bile duct fibrosis. However, we were not able to associate percutaneous biliary drainage with cholangitis in this study.

In the patients who developed a biliary stricture, nearly half of them had undergone a hepaticojejunostomy. The other patients were reconstructed with a choledochojejunostomy. For the 1550 patients who did not develop a stricture, we do not have operative detail regarding their biliary reconstruction.

Dr. James A. O'Neill, Jr. (Nashville, Tennessee): This is a very stimulating study because it has much broader application than just for pancreaticoduodenectomy as I think most people here realize.

I have a quick question for you, Dr. House. How long were the patients who were dilated and stented followed. I ask this question because in our own experience with choledochal cyst reconstruction, a similar type of reconstruction, and in the experience recently reported by Miyano from Japan, stenting and dilatation for what are basically all anastomotic strictures works only about half the time long term and so those patients will obviously end up needing to be re-done. The appreciation of the presence of a stricture may be very difficult because the signs and symptoms are very subtle until they become obvious with jaundice or stones and sepsis, so many of these strictures have not even become evident to us for a couple of years postop. So I wonder what your length of follow-up is and perhaps most pertinent would be the benign disease group.

Dr. Michael G. House (Baltimore, Maryland): For the 10 patients with benign disease, the median follow-up was just over a year from the time their percutaneous biliary drain was removed. The median time to present with a biliary stricture was 13 months, and then patients were followed for a year after they were successfully managed with balloon cholangioplasty and transhepatic stenting.

Are we underestimating our numerator, that is, the actual incidence of postoperative biliary strictures? While our patients are free to pursue care at other hospital centers, we feel that they are likely to re-present to the primary surgeon upon redeveloping jaundice after a Whipple, especially those with malignant disease originally. For 80% of patients with malignant disease, we had complete follow-up up to the time of their death or to last contact in 2004.