Low Risk Of Pancreatic Fistula Research Articles

HPB P43 Pancreatic Anastomosis Audit (PARANOIA): Initial experience of an international POPF registry

Abstract Background Post-operative pancreatic fistula (POPF) remains the primary determinant of poor outcome following pancreatoduodenectomy (PD) Risk factors are well understood but there is no apparent reduction in incidence. RCT’s are methodologically flawed to investigate POPF. PARANOIA is a registry with two novel outcomes. 1) Surgeons-specific risk-adjusted outcomes: Surgeons will observe in real time how changes to surgical technique impact upon outcomes. By having access to the registry data surgeons can explore technical factors of pancreas surgery that are associated with high or low risk of pancreatic fistula. 2)The registry will serve as a platform for international prospective studies. Methods Core dataset consists of common risk factors found within scores (aFRS, FRS, Roberts’) along with anastomotic technique and adjuncts. Initial prospective studies test topical clinical questions through embedded parallel studies. Using a stepwise approach, the registry and user network will be tested with increasingly complex study designs to determine the functionality of the registry as a novel research tool. Surgeons will have their risk-adjusted outcomes as a CUSUM plot which they can compare against anonymised surgeons by different variables. Results 232 registered surgeons across 56 countries with 776 cases. Majority of surgeons are performing open surgery (open 208 (89.7%) vs laparoscopic (11 (5.2%) vs robotic 11 (5.2%)). End-to-side was the commonest technique (88.8%) with invagination (69%) being used more than duct-to-mucosa (31%). 43.5% of surgeons used an internal stent routinely and almost all used drains (97.8%). 13% used pharmaceutical sealants whereas 28.4% used an autologous barrier. 44% used a somatosatin analogue (SSA). 70.5% reported no POPF whereas 8.4% had a CR-POPF rate. A reduced CR-POPF was associated with use of stent (p=0.008), autologous barrier (p=0.012) and SSA (p=0.049). Conclusions The PARANOIA registry has shown rapid recruitment of surgeons and data entry in pancreatic surgery can not only shorten the timeframe from study conception to dissemination of results but also provide real world data and provide comparison of outcomes between and within geographical regions, a key factor given that some patient and operative variables relevant to POPF vary across the globe. Registry data and the risk-adjusted CUSUMS can be used by surgeons to benchmark themselves against their peers and consider how modifications to their operative technique or perioperative care may affect their outcomes.

A novel anastomosis technique facilitates pancreaticojejunostomy in total laparoscopic pancreaticoduodenectomy (with video).

While the best technique for pancreatic anastomosis during Whipple's procedure remains controversial, laparoscopic pancreaticoduodenectomy (LPD) has been rapidly increasing in popularity. Because of their feasibility and reliability, new pancreatic anastomosis techniques may have vital roles when adapted for LPD. Here, we describe a new pancreaticojejunostomy (PJ) technique using three sutures (termed the "three sutures" PJ technique), which facilitates pancreatic anastomosis during total LPD. A total of 149 patients who underwent LPD using the "three sutures" PJ technique at three hospitals were included in this study (81 patients at Guangdong Provincial People's Hospital [GDPH], 60 patients at Sun Yat-Sen Memorial Hospital [SMH], and 8 patients at Affiliated Hospital of Guangdong Medical University [AHGMU]). Data on the demographic characteristics, operative outcomes, and postoperative results (pancreatic fistula rate, mortality rate, and length of hospital stay) of these patients were collected and analyzed. A surgical video showing the details of the "three sutures" PJ method was included. The mean operation times at GDPH, SMH, and AHGMU were 4.08 ± 0.99h, 4.65 ± 1.53h, and 4.67 ± 0.64h, respectively, and the average PJ times were 17.96 ± 3.49min, 18.19 ± 2.63min, and 22.5 ± 3.96min, respectively. The numbers of grade B pancreatic fistulas were 9 (11.11%), 2 (3.33%), and 1 (12.50%), respectively, and two patients had grade C fistulas, one each at GDPH and SMH. The numbers of clinically relevant postoperative pancreatic fistula (CR-POPF) were 10 (12.35%), 3 (5.00%), and 1 (12.50%) in each center, respectively. The overall rate of CR-POPF was 9.40% (14/149) among patients of all three centers. The perioperative mortality rate was 0%. The "three sutures" PJ technique for total LPD is a safe and reliable method, with a low risk of pancreatic fistula, short anastomosis time, and steep learning curve.

The outcome of laparoscopic pancreaticoduodenectomy is improved with the learning curve and patients' selection. Analysis in 122 patients

Background: In our first experience Laparoscopic pancreaticoduodenectmoy (LPD) was associated with higher morbidity and we restricted our indications to patients at lower risk of pancreatic fistula (PF). Our aim was to analyze the learning curve effect on the outcome. Methods and patients: Between April 2011- September 2018, 122 LPD were performed by pure laparoscopic approach and one layer pancreaticojejunal anastomosis. The demographics, surgical and the outcome data of the first 61 LPD were compared to the last 61 LPD. Results: No difference regarding age (58 vs 59, p=0.844), female (44% vs 48%, p=0,716) and BMI (23 vs 24, p=0.584). Less resections for pancreatic adenocarcinoma (31% vs 20%, p=0.145) and for ampulloma (23% vs 16%, p=0.362). Less operative time (348 vs 310, p=0.001), Less blood loss (348 vs 247 vs, p=0.035), but similar transfusion (10% vs 8%, p=0.752) and conversion (7% vs 8%, p=0,729). Similar 90 days mortality (3% vs 5%). Less overall morbidity (75% vs 72%,p=0.641), less grades B and C PF (36% vs 29%, p=0.396), less bleeding (25% vs 17%, p=0.703), less re-interventions for severe complications (16 % vs 9%, p=0.039), less readmission (7% vs 5%,p=0.714), same rate of delayed gastric emptying (15% vs 15%,p=0.970), similar drained collections (3% vs 5%) but more biliary fistula (10% vs 13%,p=0.548). Hospital stay was shorter (26 vs 21, p=0.081). Conclusion: Although in the second period LPD was less frequently performed for pancreatic adenocarcinoma, at lower risk of PF, the outcome was better related to patient selection, improved surgical technique and management.

National Pancreatic Fistula Rates after Minimally Invasive Pancreaticoduodenectomy: A NSQIP Analysis

There is a substantial learning curve associated with minimally invasive pancreaticoduodenectomy (MIPD). We sought to determine if national MIPD pancreatic fistula rates are decreasing with time. All patients undergoing elective MIPD and accrued into the pancreatectomy-targeted NSQIP database between 2014 and 2017 were included in the study. Trends in MIPD outcomes by year were examined using Cochran-Armitage and Mann-Kendall tests for trend. Multivariable logistic regression was used to assess for an independent association between increasing year of operation and pancreatic fistula. There were 1,096 patients who underwent MIPD between 2014 and 2017. There was a significant trend toward decreasing pancreatic fistula rates (23.6% vs 19.2% vs 14.9% vs 12.7%, p<0.01) and clinically relevant pancreatic fistula rates (18.3% vs 15.4% vs 11.1% vs 9.1%, p < 0.01) by increasing year. In multivariable analysis, increasing year of operation was independently protective against pancreatic fistula (odds ratio [OR] 0.76 per year, p < 0.01) and clinically relevant pancreatic fistula (OR 0.73 per year, p < 0.01). Patients without pancreas ducts <3 mm or soft pancreas gland texture experienced a significant decreasing trend in pancreatic fistula rates (23.7% vs 13.2% vs 10.3% vs 8.0%, p < 0.01) and clinically relevant pancreatic fistula rates (18.3% vs 9.1% vs 5.2% vs 6.0%, p < 0.01), respectively, by increasing year. However, there was not a significant trend in pancreatic fistula rate or clinically relevant fistula rate among patients having either pancreas ducts < 3 mm or soft gland texture. National MIPD pancreatic fistula rates are improving with time. A major contributing factor for this finding is better outcomes in patients who are at lower risk of pancreatic fistula, which could be a reflection of evolving minimally invasive anastomotic techniques.

A novel technique of pancreaticojejunostomy for laparoscopic pancreaticoduodenectomy.

Pancreaticojejunostomy (PJ) reconstruction is the Achilles' heel of laparoscopic pancreaticoduodenectomy (LPD). However, only a few studies have focused on the performance of this difficult procedure laparoscopically. We present a safe and feasible technique of duct-to-mucosa pancreaticojejunostomy for LPD, named Bing's anastomosis. Our study included 238 cases of LPDs that underwent Bing's anastomosis. Data on the demographic characteristics, operative outcomes (total operative time, PJ duration, and estimated blood loss), and postoperative results (length of hospital stay, recovery of bowel function, and rates of postoperative morbidity and mortality) of the cases were prospectively collected and retrospectively analyzed. Only one patient (0.4%) in our series required conversion to open surgery as a result of uncontrolled bleeding from the superior mesenteric artery. The average operative time was 358min (220min to 495min). The mean duration for PJ was 23min (19min to 33min). The mean estimated blood loss was 112ml (50ml to 800ml). The overall incidence of pancreatic fistula was 21.4% and included 42 cases (17.6%) of biochemical leak, eight cases (3.4%) of Grade B, and one case (0.4%) of Grade C pancreatic fistulas. The 90-day mortality was 0.4%. Bing's anastomosis is a safe, reliable, and rapid PJ technique for LPD that is associated with favorable outcomes and a low risk of pancreatic fistula. However, its safety and feasibility should be verified by performing prospective randomized controlled trials at different institutions.

The outcome of Laparoscopic pancreaticoduodenectomy is better with the learning curve. analysis in 100 patients

Introduction: In our first experience Laparoscopic pancreaticoduodenectmoy (LPD) was associated with higher morbidity and we restricted our indications to patients at lower risk of pancreatic fistula (PF). Our aim was to analyse the learning curve effect on the outcome. Method: Between April 2011 – September 2017, 100 LPD were performed by pure laparoscopic approach and one layer pancreaticojejunal anastomosis. The demographics, surgical and the outcome data of the last 50 LPD were compared to the first 50 LPD. Results: No difference regarding age (57 vs 60, p = 0.20), female (42% vs 42%) and BMI (24 vs 23, p = 0.39). Less resections for pancreatic adenocarcinoma (22% vs 32%, p = 0.047) and for ampulloma (14 vs 26, p = 0.26). No difference on the operative time (335 vs 342, p = 0.62) and conversion (8% vs 8%) but Less blood loss (250 vs 368 vs, p = 0.024) and transfusion (4% vs 12%, p = 0.50). Similar 90 days mortality (4% vs 4%). Less overall morbidity (68% vs 76%, p = 0.37), less grades B and C PF (33% vs 42%, p = 0.33), less bleeding (18% vs 26%, p = 0.47), less re-interventions for severe complications (6 % vs 14%, p = 0.039), less readmission (4% vs 8%, p = 0.40), less delayed gastric emptying (10% vs 16%, p = 0.37), similar drained collections (4% vs 4%) but more biliary fistula (18% vs 8%, p = 0.137). Hospital stay was shorter (22 vs 28, p = 0.033). Conclusions: Although in the second period less resection were done for pancreatic adenocarcinoma, at lower risk of PF, the outcome of LPD was better related to patient selection, improved surgical technique and management.

Management of delayed stenosis of pancreatico-enteric anastomosis following pancreatoduodenectomy

Stenosis of the pancreatico-enteric anastomosis following pancreatoduodenectomy (PD), a late post-operative complication that is seen mainly after PD for diseases with good prognosis, has been reported in less than 3% of cases in the literature. Most often asymptomatic, pancreatic-enteric anastomotic stenosis can lead to pancreatitis, pain or pancreatic insufficiency. Symptomatic stenosis is difficult to treat and its management is not standardized. Magnetic resonance cholangiopancreatography is the best investigation to confirm the diagnosis of stenosis. The Endoscopic UltraSonography (EUS)«rendezvous» technique, associating an endoscopic approach and EUS-guided puncture of the main pancreatic duct, has been available since 2010. Of note, however, the failure rate of the EUS series is as high as 25%, leading to repeat procedures. Surgical reconstruction of the anastomosis has been reported with good results in terms of morbidity. Surgical re-do of the pancreatico-enteric anastomosis for stenosis following PD carries a low risk of pancreatic fistula (around 5%) and an overall morbidity rate of around 20%.

Stents for the prevention of pancreatic fistula following pancreaticoduodenectomy.

Several studies have demonstrated that the use of pancreatic duct stents following pancreaticoduodenectomy is associated with a lower risk of pancreatic fistula. However, to date there is a lack of accord in the literature on whether the use of stents is beneficial and, if so, whether internal or external stenting, with or without replacement, is preferable. This is an update of a systematic review. To determine the efficacy of pancreatic stents in preventing pancreatic fistula after pancreaticoduodenectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science, and four major Chinese biomedical databases up to November 2015. We also searched several major trials registers. Randomized controlled trials (RCTs) comparing the use of stents (either internal or external) versus no stents, and comparing internal stents versus external stents, replacement versus no replacement following pancreaticoduodenectomy. Two review authors independently extracted the data. The outcomes studied were incidence of pancreatic fistula, need for reoperation, length of hospital stay, overall complications, and in-hospital mortality. We showed the results as risk ratio (RR) or mean difference (MD), with 95% confidence interval (CI). We assessed the quality of evidence using GRADE (http://www.gradeworkinggroup.org/). We included eight studies (1018 participants). The average age of the participants ranged from 56 to 68 years. Most of the studies were conducted in single centers in Japan (four studies), China (two studies), France (one study), and the USA (one study). The risk of bias was low or unclear for most domains across the studies. Stents versus no stentsThe effect of stents on reducing pancreatic fistula in people undergoing pancreaticoduodenectomy was uncertain due to the low quality of the evidence (RR 0.67, 95% CI 0.39 to 1.14; 605 participants; 4 studies). The risk of in-hospital mortality was 3% in people who did receive stents compared with 2% (95% CI 1% to 6%) in people who had stents (RR 0.73, 0.28 to 1.94; 605 participants; 4 studies; moderate-quality evidence). The effect of stents on reoperation was uncertain due to wide confidence intervals (RR 0.67, 0.36 to 1.22; 512 participants; 3 studies; moderate-quality evidence). We found moderate-quality evidence that using stents reduces total hospital stay by just under four days (mean difference (MD) -3.68, 95% CI -6.52 to -0.84; 605 participants; 4 studies). The risk of delayed gastric emptying, wound infection, and intra-abdominal abscess was uncertain (gastric emptying: RR 0.75, 95% CI 0.24 to 2.35; moderate-quality evidence) (wound infection: RR 0.73, 95% CI 0.40 to 1.32; moderate-quality evidence) (abscess: RR 1.38, 0.49 to 3.85; low-quality evidence). Subgroup analysis by type of stent provided limited evidence that external stents lead to lower risk of fistula compared with internal stents. External versus internal stentsThe effect of external stents on the risk of pancreatic fistula, reoperation, delayed gastric emptying, and intra-abdominal abscess compared with internal stents was uncertain due to low-quality evidence (fistula: RR 1.44, 0.94 to 2.21; 362 participants; 3 studies) (reoperation: RR 2.02, 95% CI 0.38 to 10.79; 319 participants; 3 studies) (gastric emptying: RR 1.65, 0.66 to 4.09; 362 participants; 3 studies) (abscess: RR 1.91, 95% CI 0.80 to 4.58; 362 participants; 3 studies). The rate of in-hospital mortality was lower in studies comparing internal and external stents than in those comparing stents with no stents. One death occurred in the external-stent group (RR 0.33, 0.01 to 7.99; low-quality evidence). There were no cases of pancreatitis in participants who had internal stents compared with three in those who had external stents (RR 0.15, 0.01 to 2.73; low-quality evidence). The difference between internal and external stents on total hospital stay was uncertain due to the wide confidence intervals around the average effect of 1.7 days fewer with internal stents (9.18 days fewer to 5.84 days longer; 262 participants; 2 studies; low-quality evidence). The analysis of wound infection could not exclude a protective effect with either approach (RR 1.41, 0.44 to 4.48; 319 participants; 2 studies; moderate-quality evidence). Operative replacement of pancreatic juice versus not replacing pancreatic juice There was insufficient evidence available from a small trial to ascertain the effect of replacing pancreatic juice. This systematic review has identified limited evidence on the effects of stents. We have not been able to identify convincing direct evidence of superiority of external over internal stents. We found a limited number of RCTs with small sample sizes. Further RCTs on the use of stents after pancreaticoduodenectomy are warranted.

Laparoscopic Pancreaticoduodenectomy Should Not Be Routine for Resection of Periampullary Tumors

Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited. Our aim was to compare the outcomes of LPD and open pancreaticoduodenectomy (OPD). Between April 2011 and April 2014, 46 LPD were performed and compared with 46 OPD, which theoretically can be done by the laparoscopic approach. Patients were also matched for demographic data, associated comorbidities, and underlying disease. Patient demographics and perioperative and postoperative outcomes were studied from our single center prospective database. Lower BMI (23 vs 27 kg/m(2), p < 0.001) and a soft pancreas (57% vs 47%, p = 0.38) were observed in patients with LPD, but there were no differences in associated comorbidities or underlying disease. Surgery lasted longer in the LPD group (342 vs 264 minutes, p < 0.001). One death occurred in the LPD group (2.1% vs 0%, p = 0.28) and severe morbidity was higher (28% vs 20%, p = 0.32) in LPD due to grade C pancreatic fistula (PF) (24% vs 6%, p = 0.007), bleeding (24% vs 7%, p = 0.02), and revision surgery (24% vs 11%, p = 0.09). Pathologic examination for malignant diseases did not identify any differences between the LPD and OPD as far as size (2.51 vs 2.82 cm, p = 0.27), number of harvested (20 vs 23, p = 0.62) or invaded (2.4 vs 2, p = 0.22) lymph nodes, or R0 resection (80% vs 80%; p = 1). Hospital stays were similar (25 vs 23 days, p = 0.59). There was no difference in outcomes between approaches in patients at a lower risk of PF. This study found that LPD is associated with higher morbidity, mainly due to more severe PF. Laparoscopic pancreaticoduodenectomy should be considered only in the subgroup of patients with a low risk of PF.

Pancreaticojejunostomy with double-layer continuous suturing is associated with a lower risk of pancreatic fistula after pancreaticoduodenectomy: A comparative study

Background: Postoperative pancreatic fistula (POPF) remains a leading cause of morbidity and mortality after pancreaticoduodenectomy (PD). Thus, a number of technical modifications regarding the pancreatoenteric anastomosis after PD have been proposed to reduce POPF rate. In this article we focused on evaluating whether the double layer continuous suture technique was better than the double layer interrupted suture technique in pancreatic–enteric anastomosis after PD. Material and methods: From 2012 to 2013, 114 patients (67 men and 47 women) underwent a pancreatic–enteric anastomosis after PD were analysed. There were 79 patients using the double layer continuous suture technique and 35 patients were using the double layer interrupted suture technique. The operation time, intraoperative blood loss, initial postoperative day of oral feeding, postoperative hospital stay and the presence of main early complications (pancreatic fistulas) were evaluated by chi-square test or unpaired t-test in this study. Results: Pancreatic fistulas occurred in patients with double layer continuous suture was 17.14%(6/35), and in those with interrupted suture was 39.24%(31/79) (p < 0.05). Grade A of POPF was found in 4 patients (4/35, 11.43%) of the double layer continuous suture group and in 5 patients (5/79, 6.33%) of the double layer interrupted suture group. Grade B of POPF was identified only in 1 patients (1/35, 2.83%) of the double layer continuous suture group and in 23 patients (23/79, 29.11%) of the double layer interrupted suture group. The presence of Grade C pancreatic fistulas was only documented in one patient in the double layer continuous suture group and 3 patients in the interrupted suture group. No operative or in-hospital deaths occurred. Conclusions: The double-layer continuous suturing after PD is safe, reliable, rapid, favorable and associated with a lower risk of pancreatic fistula than the double layer interrupted suture.

Initial Experiences of an Enhanced Recovery Programme After Pancreaticoduodenctomy

Context Enhanced recovery after surgery (ERAS) programmes decrease morbidity and duration of stay after colorectal surgery. There is little information about their role in complex procedures, such as pancreaticoduodenectomy. Objective To evaluate the safety, feasibility, and the short-term outcomes of enhanced recovery after pancreatico­duodenectomy (ERAPD) programme. Methods Beginning in January 2013 a multidisciplinary protocol of ERAPD was developed at our institution. In all the cases, the reconstruction after pancreaticoduodenectomy included duct-to-mucosa pancreaticojejunostomy. This protocol included near-zero fluid balance, mid-thoracic epidural analgesia, removal of nasogastric tube before the extubation, liquid diet in post-operative day 1 and solid diet in post-operative day 2, as well as early drains removal according to amylase value in drains (AVD). Overall, 29 patients were included in the ERAPD group (ERAPD+) and were compared with other 29 patients (ERAPD-) previously treated by the same surgical team. Results The two groups were similar with respect to age, gender, diagnosis, and operative time. There were no significant differences in the incidence of post-operative complications (55% for ERAPD+ versus 52% for ERAPD-, P=0.792). The rate of pancreatic fistula was 14% in the ERAPD+ group compared with 28% in the ERAPD- group (P=0.195). In younger patients (age <70 years), ERAPD+ patients had a lower risk of pancreatic fistula compared with ERAPD- patients (6% versus 33%, P=0.042). The incidence of delayed gastric emtpying syndrome was 10% in the ERAPD+ group compared with 7% in the ERAPD- group. The overall length of hospital stay was 12 days in both the groups (P=1.000). Conclusion The implementation of an ERAS programme after pancreaticoduodenectomy was safe and feasible. This protocol was associated with a tendency toward a lower incidence of pancreatic fistula although not statistically significant. ERAPD+ patients younger than 70 years have the best results in terms of reduction of pancreatic fistula rate.

Selective Policy of No Drain after Pancreaticoduodenectomy Is a Valid Option in Patients at Low Risk of Pancreatic Fistula: A Case‐Control Analysis

Abdominal drainage is routinely performed after pancreaticoduodenectomy (PD), but this policy has recently been challenged. The aim of the present study was to assess whether abdominal drainage could be omitted after PD in patients at low risk of pancreatic fistula (PF). From 2009 to 2011, 27 consecutive patients underwent PD without abdominal drainage. Their preoperative characteristics and postoperative outcomes were compared to those of 27 matched patients undergoing PD with prophylactic drainage. Patients were matched 1:1 in terms of demographic data, preoperative weight loss, preoperative biliary drainage, surgical indication, and main risk factors of PF (pancreatic texture, main duct size, and body mass index). Overall morbidity rates (no drainage, 56 % vs. drainage, 70 %; p < 0.4) and operative mortality (1 patient in each group) were similar in both groups. The two groups did not differ significantly in terms of delayed gastric emptying (15 vs. 11 %; p = 0.68), and chylous ascites (4 vs. 15 %; p = 0.35). Radiological or surgical interventions for surgical complications were required in 2 patients (1 in each group). Pancreatic fistula rate (0 vs. 22 %; p = 0.009) and hospital stay (10 vs. 15 days; p = 0.004) were significantly reduced in the no drainage group as compared to the drainage group. The hospital readmission rate was similar in the two groups (no drainage, 3.7 vs. 0 %; p = 0.31). This study suggests that abdominal drainage should not be considered routinely after PD in patients at low risk of PF. A no drain policy may reduce hospital stay after PD.

Pancreatoduodenectomy with a Modified Duct-To-Mucosa Pancreaticojejunostomy: An Analysis of 101 Consecutive Patients

The aim of the study was to analyze in-hospital morbidity and mortality after pancreatoduodenectomy (PD) with a modified duct-to-mucosa pancreaticojejunostomy. We retrospectively analyzed 101 consecutive patients who underwent PD at our center between January 2002 and December 2010. Two-layered duct-to-mucosa pancreaticojejunostomy was performed over an internal transanastomotic stent in all patients. The overall in-hospital morbidity and mortality rate was 48% and 6%, respectively. Three patients died as a consequence of local complications including mesenteric ischemia in two and acute necrotizing pancreatitis in one case. Pancreatic fistula occurred in one (1%) patient and was treated conservatively with good outcome. The wound infection was the most common surgical complication (20/101; 20%) and occurred more often in patients who had a biliary stent inserted endoscopically prior to surgery (15/38; 39%), as compared to those without the stent (5/63; 8%; p=0.0003). The results of the present study suggest that a two-layered duct-to-mucosa pancreaticojejunostomy with internal transanastomotic stent is a safe anastomosis, associated with a very low risk of pancreatic fistula. The presence of a biliary stent at the time of surgery represents a risk factor for the development of postoperative wound infection.

Early Versus Late Drain Removal After Standard Pancreatic Resections

The role of surgically placed intra-abdominal drainages after pancreatic resections has not been clearly established. In particular, their effect on morbidity rates and the optimal timing for their removal remains controversial. A total of 114 eligible patients who underwent standard pancreatic resections and at low risk of postoperative pancreatic fistula according to our institutional protocol (amylase value in drains < or =5000 U/L on postoperative day [POD] 1) were randomized on POD 3 to receive either early (POD 3) or standard drain removal (POD 5 or beyond). The primary end point of the study was the incidence of pancreatic fistula. Secondary endpoints included abdominal complications, pulmonary complications, in-hospital stay, and perioperative mortality. Cost-analysis between the 2 groups was also made. Early drain removal was associated with a decreased rate of pancreatic fistula (P = 0.0001), abdominal complications (P = 0.002), and pulmonary complications (P = 0.007). Median in-hospital stay was shorter (P = 0.018), and hospital costs decreased (P = 0.02). Mortality was nil. A significant association with pancreatic fistula was found for timing of drain removal (P < 0.001), unintentional weight decrease before surgery (P = 0.022), type of pancreas texture (P = 0.015), serum amylase levels on POD 1 (P = 0.001), and albumin levels on POD 1 (P = 0.039). Multivariate analysis showed that timing of drain removal (P = 0.0003) and unintentional weight decrease before surgery (P = 0.02) were independent risk factors of pancreatic fistula. In patients at low risk of pancreatic fistula, intra-abdominal drains can be safely removed on POD 3 after standard pancreatic resections. A prolonged period of drain insertion is associated with a higher rate of postoperative complications with increased hospital stay and costs. The manuscript is a randomized trial, registered in the NLM database as NCT00931554.