Reinforced versus standard stapler transection on postoperative pancreatic fistula in distal pancreatectomy: multicentre randomized clinical trial.

BACKGROUND: Postoperative pancreatic fistula is the leading cause of morbidity after distal pancreatectomy. Strategies investigated to reduce the incidence have been disappointing. Recent data showed a reduction in postoperative pancreatic fistula with the use of synthetic mesh reinforcement of the staple line. METHODS: An RCT was conducted between May 2014 and February 2016 at four tertiary referral centres in Sweden. Patients scheduled for distal pancreatectomy were eligible. Enrolled patients were randomized during surgery to stapler transection with biological reinforcement or standard stapler transection. Patients were blinded to the allocation. The primary endpoint was the development of any postoperative pancreatic fistula. Secondary endpoints included morbidity, mortality, and duration of hospital stay. RESULTS: Some 107 patients were randomized and 106 included in an intention-to-treat analysis (56 in reinforced stapling group, 50 in standard stapling group). No difference was demonstrated in terms of clinically relevant fistulas (grade B and C): 6 of 56 (11 per cent) with reinforced stapling versus 8 of 50 (16 per cent) with standard stapling (P = 0.332). There was no difference between groups in overall postoperative complications: 45 (80 per cent) and 39 (78 per cent) in reinforced and standard stapling groups respectively (P = 0.765). Duration of hospital stay was comparable: median 8 (range 2-35) and 9 (2-114) days respectively (P = 0.541). CONCLUSION: Biodegradable stapler reinforcement at the transection line of the pancreas did not reduce postoperative pancreatic fistula compared with regular stapler transection in distal pancreatectomy. Registration number: NCT02149446 (http://www.clinicaltrials.gov).

Predictive Factors for Postoperative Pancreatic Fistula-A Swedish Nationwide Register-Based Study.

BACKGROUND: A serious complication after pancreatoduodenectomy (PD) is postoperative pancreatic fistula (POPF). The aim of this study was to analyse the incidence and predictive factors for POPF by using a large nationwide cohort. METHODS: Data from the Swedish National Registry for Pancreatic and Periampullary Cancer for all patients undergoing a PD from 2010 until 30th June 2018 were collected. The material was analysed in two groups, no POPF and clinically relevant (grade B and C) POPF. RESULTS: A total of 2503 patients underwent PD, of which 245 (10%) developed POPF. Patients with POPF had significantly more overall complications (Clavien Dindo ≥3a, 75% vs. 21%, p < 0.001) and longer hospital stay (median 23 [16-35] vs. 11 [8-15], p < 0.001) than patients without POPF. The risk of POPF was higher with increased BMI (OR 1.08, p < 0.001). Preoperative presence of diabetes (OR 0.52, p = 0.012) and preoperative biliary drainage (OR 0.34, p < 0.001) reduced the risk of POPF. Reconstruction with pancreaticojejunostomy caused a more than two folded increase in POPF compared with pancreaticogastrostomy (OR 2.41, p < 0.001). Weight gain ≥2 kg on postoperative day 1 was also a risk factor (OR 1.76, p < 0.001). CONCLUSION: A high BMI, a pancreaticojejunostomy and postoperative weight gain were risk factors for developing POPF. Diabetes or preoperative biliary drainage was protective.

Impact of a fast-track surgery programme for pancreaticoduodenectomy.

BACKGROUND: Fast-track (FT) programmes are multimodal, evidence-based approaches to optimize patient outcome after surgery. The aim of this study was to evaluate the safety, clinical outcome and patients' experience of a FT programme after pancreaticoduodenectomy (PD) in a high-volume institution in Sweden. METHODS: Consecutive patients undergoing PD were studied before and after implementation of the FT programme. FT changes included earlier mobilization, standardized removal of the nasogastric tube and drain, and earlier start of oral intake. Patient experience was evaluated with European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-PAN26 questionnaires 2 weeks before and 4 weeks after surgery. RESULTS: Between 2011 and 2014, 100 consecutive patients undergoing PD were studied, of whom 50 received standard care (controls), followed by 50 patients treated after implementation of the FT programme. The nasogastric tube was removed significantly earlier in the FT group, and these patients were able fully to tolerate fluids and solid food sooner after PD. Delayed gastric emptying was significantly reduced in the FT group (26 versus 48 per cent; P = 0.030). Overall morbidity remained unchanged and there were no deaths in either group. Postoperative length of hospital stay was reduced from 14 to 10 days and hospital costs were decreased significantly. Health-related quality-of-life questionnaires showed similar patterns of change, with no significant difference between groups before or after surgery. CONCLUSION: The FT programme after PD was safe. Delayed gastric emptying, hospital stay and hospital costs were all reduced significantly. Although patients were discharged 4 days earlier in the FT group, this did not influence health-related quality of life compared with standard care.

Sustainability of an Enhanced Recovery Program for Pancreaticoduodenectomy with Pancreaticogastrostomy.

BACKGROUND:: Enhanced recovery program for pancreaticoduodenectomy have become standard care. Little is known about adherence rates and sustainability of the program, especially when pancreaticogastrostomy is used in reconstruction. The aim of this study was, therefore, to evaluate adherence rates and continued outcome, after implementation of an enhanced recovery program. METHODS:: Consecutive patients undergoing pancreaticoduodenectomy at the Department of Surgery, Skåne University Hospital, Lund, Sweden were followed, after implementation of enhanced recovery program, October 2012. In April 2015, some items in the enhanced recovery program were modified, namely earlier removal of nasogastric tubes and abdominal drain. The patients were analyzed in three groups, the implementation group (control) and two post-implementation groups; intermediate and modified group. Sustainability was assessed according to length of stay and adherence rate. RESULTS:: In total, 160 patients were identified. The overall protocol adherence rate increased from 65% to 72%, p = 0.035. While the pre- and intraoperative protocol items were fulfilled to more than >90%, the postoperative were lower, but increasing over time; 48%, 50%, and 58%, p = 0.033. Postoperative complications and hospital length of stay did not change significantly. CONCLUSION:: The positive outcome of an enhanced recovery program for pancreaticoduodenectomy was reasonably well sustained. Compliance with the protocol has increased, but strict adherence remains a challenge, especially with the postoperative items.

Catheter-directed foam sclerotherapy for insufficiency of the great saphenous vein: occlusion rates and patient satisfaction after one year.

OBJECTIVES: This study aims to describe a technique for catheter-directed foam sclerotherapy (CDS) of great saphenous vein (GSV) insufficiency and report occlusion rate and patient satisfaction after a single treatment. METHODS: About 100 patients were included. The GSV was accessed at knee level. With the method of Tessari 10 mL sclerosant foam was made (2 mL 3% polidocanol and 8 mL air) and delivered along the GSV while the catheter was withdrawn. At two weeks and at one year after treatment the patients were evaluated. RESULTS: CDS was successfully performed in 94 of the 100 patients. After one year, 84% of the patients were satisfied. Seventy percent of the GSV were completely occluded, 14% were partly occluded and 15% were recanalized. No serious side-effects occurred. CONCLUSIONS: CDS is safe. Patient satisfaction is very satisfying and the occlusion rate is promising after a single treatment. Repeated treatments and technical development may achieve higher occlusion rates.