Dual modality drainage for symptomatic walled-off pancreatic necrosis reduces length of hospitalization, radiological procedures, and number of endoscopies compared to standard percutaneous drainage.

BACKGROUND: Symptomatic walled-off pancreatic necrosis (WOPN) treated with dual modality endoscopic and percutaneous drainage (DMD) has been shown to decrease length of hospitalization (LOH) and use of radiological resources in comparison to standard percutaneous drainage (SPD). AIM: The aim of this study is to demonstrate that as the cohort of DMD and SPD patients expand, the original conclusions are durable. METHODS: The database of patients receiving treatment for WOPN between January 2006 and April 2011 was analyzed retrospectively. PATIENTS: One hundred two patients with symptomatic WOPN who had no previous drainage procedures were evaluated: 49 with DMD and 46 with SPD; 7 were excluded due to a salvage procedure. RESULTS: Patient characteristics including age, sex, etiology of pancreatitis, and severity of disease based on computed tomographic severity index were indistinguishable between the two cohorts. The DMD cohort had shorter LOH, time until removal of percutaneous drains, fewer CT scans, drain studies, and endoscopic retrograde cholangiopancreatography (ERCPs; p < 0.05 for all). There were 12 identifiable complications during DMD, which were successfully treated without the need for surgery. The 30-day mortality in DMD was 4% (one multi-system organ failure and one out of the hospital with congestive heart failure). Three patients receiving SPD had surgery, and three (7%) died in the hospital. CONCLUSION: DMD for symptomatic WOPN reduces LOH, radiological procedures, and number of ERCPs compared to SPD.

Intraoperative cholangiography lowers the risk of bile duct injury during cholecystectomy.

Intraoperative cholangiography (IOC) can help to avoid bile duct injury for at least three reasons. First, IOC shows the immense diversity of the biliary tree and its patterns of biliary anomalies. Thus, IOC is a great provider of profound knowledge concerning the biliary tree. Second, a surgeon, over time, becomes an expert on how to read an IOC. The surgeon then is able to discover whether the patient is at risk for biliary injury. Third, if an injury has already occurred, then an IOC can provide early detection and, if correctly interpreted, the injury is not worsened. Thus, IOC offers an opportunity to prevent error through profound knowledge of biliary diversity and real-time imaging.

NIS vs SAGES: a comparison of national and voluntary databases.

BACKGROUND: Surgical outcomes are increasingly examined in an effort to improve quality and reduce medical error. The Nationwide Inpatient Sample (NIS) is a retrospective, claims-derived and population-based database and the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Outcomes Project is a prospective, voluntary and specialty surgeon database. We hypothesized that these two sources of outcome data would differ in regard to a single, commonly performed procedure. METHODS: Both the NIS, a national sample of all nonfederal hospital discharges, and the gastroesophageal reflux disease log of the SAGES Outcomes Project were queried for all fundoplications performed between 1999 and 2001 using either ICD-9 procedure code 44.66 or CPT codes 43280 or 43324. Patients with an emergency admission, age <17 years, and/or diagnoses for either esophageal cancer or achalasia were excluded. Both demographic and outcome variables were compared by either t-test or chi-square analysis, with a p value of <0.05 as significant. RESULTS: Both data sets were comparable for age and gender; however, the SAGES group had a higher rate of teaching hospital affiliation (71 vs 48%, p < 0.001). SAGES fundoplications had a consistently higher rate of comorbidities, including Barrett's esophagus (2.3 vs 1.1%, p = 0.005). The NIS fundoplications had a clear trend toward more associated procedures, including cholecystectomy (7.2 vs 2%, p < 0.001). Complication rates for the NIS data set were higher, including pulmonary complications (1.7 vs 0.5%, p = 0.03). No statistically significant differences existed between the two data sets for either length of stay or mortality. CONCLUSIONS: The two databases indicate that fundoplication is an operation with low morbidity and mortality. The SAGES Outcomes Project demonstrated that participating surgeons had a higher affiliation with teaching hospitals, higher reporting of comorbidity, and lower associated procedures than the NIS. Despite having more comorbidity and technical difficulty, patients from the SAGES Outcomes Project had equivalent or lower complication rates.

Pancreatic cancer: surgery alone is not sufficient.

For a patient with resected pancreatic cancer at the head of the pancreas, the goal of the medical community in the new millennium is a long-term survival rate exceeding 50% at 5 years. This goal can best be achieved with the following formula: accurate staging by improved imaging that includes laparoscopy for selected patients with locally extensive disease using computed tomography; a balanced resection, not too extensive and not too limited; centralized treatment in high-volume centers, which includes not just the surgeons and hospitals, but also the chemotherapy infusion units; and use of an effective adjuvant or neoadjuvant treatment in which toxicity is associated with efficacy. The ideal outcome for the surgeon is delivery of a patient who has been accurately staged to receive the most appropriate treatment in a timely fashion for an effective chemoradiotherapy protocol. To do this, the surgeon should use objective benchmarks of safe pancreatic resection, which involves resecting only enough, achieving low blood loss, and achieving a minimal length of hospital stay. The outcome is a patient who has optimized his or her gastrointestinal, endocrine, and exocrine functions and is ready for adjuvant treatment 6 weeks after resection. Surgery alone is not sufficient.

Analysis of the SAGES outcomes initiative cholecystectomy registry.

BACKGROUND: In 1999, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) introduced the SAGES Outcomes Initiative as a method for its members to use for tracking their own outcomes. This report provides a descriptive analysis of the cholecystectomy database. METHODS: The SAGES Outcome Initiative database was accessed for all gallbladder cases from September 1999 to February 2005. The data from the preoperative, intraoperative, and postoperative entries were summarized. These data are purely descriptive, and no statistical analysis was performed. RESULTS: The gallbladder registry contained 3,285 cases, with 2,005 follow-up cases. Most patients were employed women with some comorbidities who had elective surgery under general anesthesia. Most of the operating surgeons were attending surgeons and surgical assistants. Most of the patients had biliary colic, and symptoms were improved for more than 95% of the patients. More than 90% of the cases were managed laparoscopically, with a conversion rate of 3%. Biliary imaging was used in the vast majority of cases, with most shown to be normal. Intraoperative gallbladder perforation was common, with bile duct injury occurring in 0.25% of cases. The most frequently cited postoperative event was wound infection, with most complications classified as class 1. More than 95% of the patients were able to return to work. CONCLUSIONS: The SAGES Outcomes Initiative database demonstrates that most participating SAGES members perform laparoscopic cholecystectomies themselves using intraoperative cholangiograms. Adverse outcomes are few, with most patients able to return to normal activity. Importantly, there were relatively few missing data points, implying that when surgeons enter data, the information is relatively complete.

Analysis of the SAGES Outcomes Initiative groin hernia database.

BACKGROUND: In 1999, the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) introduced the SAGES Outcomes Initiative as a way for its members to track their own outcomes. It contains perioperative and postoperative data on nearly 20,000 operations. This report provides a descriptive analysis of the groin hernia database. METHODS: The SAGES Outcomes Initiative database was accessed for all groin hernia cases from September 1999 to February 2005. The data from the preoperative, intraoperative, and postoperative entries were summarized. These data are purely descriptive and no statistical analysis was done. RESULTS: The hernia registry contains 1,607 entries, with 1,070 follow-up entries. Males comprised 85% of patients, 63% were employed, 62% had at least one comorbidity, with 84% ASA class I or II. Primary, unilateral hernia accounted for 86% of cases, whereas 14% were recurrent, 11% bilateral, 6% incarcerated, and 3% required emergency repair. The operating surgeon was the attending surgeon in 83% of cases. Anesthetic techniques were general anesthesia in 74% of cases, regional in 7%, and local in 34%, with only 16% of cases local only. Most patients had symptomatic hernias and symptoms were improved in more than 95% of patients. Most repairs were open, although 45% were endoscopic. The most frequently cited postoperative event was significant bruising (6%), with more than 99% of complications being class I or II. More than 95% of patients were able to return to work by the first postoperative visit. Patients who underwent endoscopic repair were reported to have fewer days of narcotic use than patients undergoing open repairs (0 vs 3). CONCLUSIONS: First analysis of the SAGES Outcomes Initiative groin hernia database demonstrates that (a) this is one of the largest prospective; voluntary hernia registries; (b) missing data are infrequent; and (c) the data are similar to published data from national, mandatory registries and randomized trials. Although the SAGES Outcomes Initiative is a voluntary registry, initially designed for surgeon self-assessment, and it therefore has the potential for methodological concerns inherent to voluntary registries, the findings from this first analysis are encouraging. Efforts are ongoing to simplify data entry (PDA), refine data parameters, increase surgeon participation, and determine the role of data audit and thereby the potential for clinical research.

The SAGES Bariatric Surgery Outcome Initiative.

BACKGROUND: The recent initiative for identifying centers of excellence in bariatric surgery calls for documentation of surgical outcomes. The SAGES Outcomes Initiative is a national database introduced in 1999 as a method for surgeons to accumulate and compare their data with summary national data. A bariatric-specific dataset was established later in 2001. The aim of this study was to compare the outcomes of bariatric surgery from the Society of American Gastrointestinal Endoscopic Surgeons' (SAGES) bariatric database with data derived from a national administrative database of academic centers. METHODS: Between 2001 and 2004, 24 surgeons with 1,954 patients participated in the SAGES Bariatric Outcome Initiative, and 97 institutions with 42,847 patients participated in the University HealthSystem Consortium (UHC) database. Only 7 of the 24 surgeons participating in the SAGES Bariatric Outcome Initiative submitted more than 50 cases. The main outcome measures included demographics, comorbidities, type of bariatric procedure, operative time, length of hospital stay, short- and long-term complications, mortality, and weight loss. RESULTS: Both datasets were comparable for gender. Roux-en-Y gastric bypass had been performed for 88% of the patients in the SAGES database and 96% of the patients in the UHC database. Associated comorbidities were similar between the two groups except for a higher rate of hyperlipidemia for the patients in the SAGES database. The SAGES database contains more bariatric-specific information such as body mass index, operative time, blood loss, bariatric-specific complications, long-term complications, and weight loss data than the UHC database. According to the available data, no statistically significant differences exist between the two datasets in terms of perioperative complications and mortality. CONCLUSIONS: The SAGES Bariatric Outcome Initiative provides valuable bariatric-specific data not currently available in an administrative database that may be useful for benchmarking purposes. However, this database is currently underutilized.

Diagnostic laparoscopy improves staging of pancreatic cancer deemed locally unresectable by computed tomography.

BACKGROUND: Computed tomography (CT) is insensitive to small metastatic deposits in patients with pancreatic cancer. This study aimed to evaluate additional staging information obtained by laparoscopy in the subset of patients with locally extending pancreatic cancer but no evidence of distant disease using computed tomography. METHODS: Between April 2000 and February 2004, 74 patients with locally unresectable pancreatic cancer and no evidence of metastasis detected by high-quality pancreas protocol computed tomography underwent outpatient staging laparoscopy and peritoneal lavage cytology. RESULTS: Occult tumor was found during staging laparoscopy in 25 of the 74 patients (34%). The results were positive for peritoneal lavage cytology in 27% (20/74), for liver lesions in 16% (12/74), and for peritoneal implants in 7% (5/74) of the patients. Body and tail tumors were twice as likely as pancreatic head tumors to have unsuspected metastasis (53% vs 28%). CONCLUSIONS: Even the best computed tomography scan is not adequate for accurate staging of locally extended pancreatic cancer because occult distant disease will be found in half of the patients with left-sided disease and one-fourth of those with right-sided pancreatic cancer.

The long-term follow-up of patients with positive intraoperative cholangiograms during laparoscopic cholecystectomy.

BACKGROUND: The routine use of laparoscopic common bile duct exploration (LCBDE) for common bile duct (CBD) stones discovered during cholecystectomy would be further supported if the long-term outcomes were similar to those for endoscopic retrograde cholangiopancreatography with endoscopic papillotomy (ERCP/EP). METHODS: A retrospective review was completed of 151 patients who had a positive intraoperative cholangiogram (IOC) during laparoscopic cholecystectomy (LC). A "positive" IOC was defined as a filling defect or lack of contrast flow into the duodenum. A "successful" CBDE was defined as a negative IOC after completion of CBDE. Long-term follow-up was obtained using a standardized questionnaire to determine the incidence of recurrent biliary pain or need for subsequent ERCP/EP. RESULTS: CBD exploration was attempted in 142 patients (transcystic LCBDE 126 and open CBDE 16) and was successful in 107 of 142 (75%). Transcystic LCBDE was successful in 90 of 126 (71%). ERCP/EP was used in 41 patients; 35 of these cases were for failed LCBDE. Pancreatitis was not observed in any patient after CBDE but was observed in 3 of 41 patients (7.3%) after ERCP/EP. Long-term follow-up of the LCBDE versus ERCP/EP patients revealed no difference in the incidence of recurrent biliary pain or need for subsequent ERCP (mean follow-up time of 61 months). CONCLUSION: LCBDE is safe and effective in the majority of cases when an attempt at transcystic LCBDE was made. In addition, after long-term follow-up of >5 years, the outcomes were similar if the stones were removed by intraoperative laparoscopic methods versus postoperative ERCP. LCBDE seems worthy of pursuing when an intraoperative CBD stone is discovered.

A report on the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Outcomes Initiative: what have we learned and what is its potential?

INTRODUCTION: The Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Outcomes Initiative established a national database in 1999. The goal was to provide a vehicle whereby surgeons could accumulate meaningful data about their surgical activity and procedure outcomes. METHODS: Through a secure Internet site, participants entered core data at the time of operation on all patients undergoing any laparoscopic or open procedure. Procedure-specific data was accumulated for cholecystectomy, inguinal hernia, and fundoplication. A second data set was collected at the time of follow-up evaluation. Individual data and a summary of national data were available through the Web site for contemporaneous review. RESULTS: Between May 1999 and December 2001, 4,100 cases were entered by 73 surgeons, including data for 1070 cholecystectomies, 1,070 antireflux procedures, and 300 hernias. The remaining cases encompassed all other procedures. Perioperative and follow-up data showed many interesting findings. For example, 30% of cholecystectomies were first-assisted by a nonphysician. The rate of conversion from laparoscopic cholecystectomy to open surgery was 3%. In the gastroesophageal reflex disease (GERD) report on fundoplications, 21% of the patients had a previous fundoplication. This report contains a summary of the data collected during this period in the national database. CONCLUSIONS: The SAGES Outcomes Initiative allows surgeons to be involved in data collection about their practice. It provides data on the general practice of surgery, which are more useful for setting benchmarks than published data from the surgical elite.

A pancreatic ductal leak should be sought to direct treatment in patients with acute pancreatitis.

BACKGROUND: The end result of leakage of pancreatic juice into the peripancreatic space can be sterile necrosis, infected necrosis, or rupture into an adjacent hollow viscus or blood vessel (eg, colon, small bowel, or pseudoaneurysm). If a pancreatic duct (PD) leak is present, should treatment be aimed at minimizing the sequela of the leakage of pancreatic juice and not just supportive observation until a necrosectomy is required? METHODS: In 144 patients with severe pancreatitis we investigated whether the presence of a PD leak was associated with necrosis and also asked if PD leak might predict other outcomes such as a length of stay (LOS), mortality, and need for surgery. Furthermore, we questioned whether the use of endoscopic retrograde cholangiopancreatography (ERCP) to search for a PD leak might worsen the clinical outcome because of the potential for introducing microorganisms into an undrained space or exacerbating pancreatitis. RESULTS: The presence of a demonstrable pancreatic duct leak was observed in 37% of patients and was significantly associated with both a higher incidence of necrosis and prolonged LOS (> or = 20 days). These patients were 3.4 times more likely to have necrosis and 2.6 times more likely to have a prolonged LOS. When treated with a combination of percutaneous drains, pancreatic duct stents, and surgery as necessary, a PD leak (even with its higher necrosis rate) was not significantly correlated with either mortality or the need for necrosectomy. The use of ERCP was not associated with LOS, mortality, or the need for necrosectomy, provided discovered PD leaks were immediately drained. CONCLUSIONS: A PD leak is common in patients with pancreatic necrosis but it is also important to locate and decompress in order to impede progression of the disease and keep mortality low.

Pancreatic schwannoma: an uncommon but important entity.

The literature contains five single case reports of pancreatic schwannoma-two of the five occurred in patients with von Recklinghausen's disease, and three of the five proved malignant. Within a 3-month period, we resected benign pancreatic schwannomas in two patients without von Recklinghausen's disease. Both patients presented with pain that led to the discovery of a complex pancreatic mass on abdominal CT scan. Pancreatic schwannoma should be included in the differential diagnosis of cystic or solid pancreatic abnormalities on imaging studies.

The pylorus preserving Whipple procedure for the treatment of chronic pancreatitis.

A schema is developed that outlines criteria to consider more than medical therapy for patients with severe pancreatitis that develop disabling abdominal pain. If the symptomatic patient has severe chronic pancreatitis that reaches the Cambridge Class V "marked" stage of image severity then endotherapy is indicated. If endotherapy fails then surgery is indicated. Usually these patients will have pathological changes centered in the pancreatic head and PPW is performed. After an average follow-up of > 4 years PPW was observed to provide either good to excellent relief of disabling abdominal pain. These patients were highly selected by the guidance of the anatomic profile of the composite pancreas. Long-term follow-up has never been available with cancer patients after the Whipple procedure. These chronic pancreatitis patients after PPW showed few GI side effects. In addition we did not observe a predisposition for diabetes other than that from the continued parenchymal destruction from smoldering chronic pancreatitis in the pancreatic remnant. Surgeons should avoid total pancreatectomy in patients, even if the patient is already diabetic. Marginal ulceration is highly associated with the total resection. From this personal experience using anatomic criteria and close follow-up, it is hoped that the long term outcomes of pain relief in virtually all patients after PPW will represent a benchmark for results after procedures which employ less resection. Therapy should be based on reliable imaging criteria to select patients. Then the outcomes of new and promising procedures such as lithotripsy or limited head resections can be compared to the benchmarks derived after PPW. None of the new procedures, however address the main problem after PPW of remnant pancreatitis in the pancreatic body/tail. Even though this discomfort is no longer disabling after head resection remnant pancreatitis does occur in approximately one out of four patients.

Computed tomography severity index is a predictor of outcomes for severe pancreatitis.

BACKGROUND: In a small group of patients with acute pancreatitis, Balthazar and Ranson demonstrated the applicability of computed tomography (CT) criteria to predict mortality. Building upon their work with a larger group of patients with acute pancreatitis, we set out not only to demonstrate that the CT severity index can predict death, but also length of hospital stay and need for necrosectomy. METHODS: We reviewed all patients admitted to our hospital in the years 1992 to 1997 with a primary diagnosis of acute pancreatitis. Entrance criteria required that a CT scan had been performed during the hospitalization. The index CT scan was used to determine a CT severity index (the CTSI of Balthazar and Ranson). Outcomes measured were death, length of stay (LOS), and need for necrosectomy (NEC). Statistical analysis was performed using Fisher's exact and chi-square tests where appropriate. RESULTS: Between the years 1992 to 1997, 886 patients had 1,774 admissions for acute pancreatitis, of which 268 had a CT scan performed and were entered into our study. These 268 patients had a mean age of 57 years, a mean LOS of 16 days (1 to 118), and a mean CTSI of 3.9 (0 to 10). Overall mortality was 4% (n = 11). A CTSI >5 significantly correlated with death (P = 0.0005), prolonged hospital stay (P <0.0001), and need for necrosectomy (P <0.0001). Patients with a CTSI >5 were 8 times more likely to die, 17 times more likely to have a prolonged hospital course, and 10 times more likely to undergo necrosectomy than their counterparts with CT scores <5. CONCLUSIONS: These data show that the CTSI is an applicable and comparable predictor of outcomes in severe pancreatitis.

Interferon-based adjuvant chemoradiation therapy improves survival after pancreaticoduodenectomy for pancreatic adenocarcinoma.

BACKGROUND: Based on a 2-year survival of 43%, the Gastrointestinal Tumor Study Group (GITSG) recommended adjuvant 5-FU-based chemoradiation for resected patients with adenocarcinoma of the pancreatic head. Here we report improved survival over the GITSG protocol with a novel adjuvant chemoradiotherapy based on interferon-alpha (IFNalpha). METHODS: From July 1993 to September 1998, 33 patients with adenocarcinoma of the pancreatic head underwent pancreaticoduodenectomy (PD) and subsequently went on to adjuvant therapy (GITSG-type, n = 16) or IFNalpha-based (n = 17) typically given between 6 and 8 weeks after surgery. The latter protocol consisted of external-beam irradiation at a dose of 4,500 to 5,400 cGy (25 fractions per 5 weeks) and simultaneous three-drug chemotherapy consisting of (1) continuous infusion 5-FU (200 mg/m2 per day); (2) weekly intravenous bolus cisplatin (30 mg/m2 per day); and (3) IFNalpha (3 million units subcutaneously every other day) during the 5 weeks of radiation. This was then followed by two 6-week courses of continuous infusion 5-FU (200 mg/m2 per day, given weeks 9 to 14 and 17 to 22). Risk factors for recurrence and survival were compared for the two groups. RESULTS: A more advanced tumor stage was observed in the IFNalpha-treated patients (positive nodes and American Joint Committee on Cancer [AJCC] stage III = 76%) than the GITSG group (positive nodes and stage III = 44%, P = 0.052). The 2-year overall survival was superior in the IFNalpha cohort (84%) versus the GITSG group (54%). With a mean follow-up of 26 months in both cohorts, actuarial survival curves significantly favored the IFNalpha group (P = 0.04). CONCLUSIONS: With a limited number of patients, this phase II type trial suggests better survival in the interferon group as compared with the GITSG group even though the interferon group was associated with a more extensive tumor stage. The 2-year survival rate in the interferon group is the best published to date for resected pancreatic cancer. The interferon/cisplatin/5-FU-based adjuvant chemoradiation protocol appears to be a promising treatment for patients who have undergone PD for adenocarcinoma of the pancreatic head.