Ulla Klaiber

Meta-analysis of complication rates for single-loop versus dual-loop (Roux-en-Y) with isolated pancreaticojejunostomy reconstruction after pancreaticoduodenectomy

Postoperative pancreatic fistula is one of the most important and potentially severe complications after partial pancreaticoduodenectomy. In this context, the reduction of postoperative pancreatic fistula by means of a dual‐loop (Roux‐en‐Y) reconstruction with isolation of the pancreaticojejunostomy from biliary drainage has been evaluated in several studies. This systematic review and meta‐analysis summarizes evidence of effectiveness and safety of the isolation of the pancreaticojejunostomy compared with conventional single‐loop reconstruction.

Thirty years of disclosure of conflict of interest in surgery journals

BACKGROUND A conflict of interest (COI) creates the risk that a professional judgment will be unduly influenced by a secondary interest. In practice, the leading concern is the creation of bias by industry sponsorship. Several organizations for ethics in scientific publishing exist, and standardized disclosure forms have been developed. The aim of this study was to investigate the present status of the definition, management, and disclosure of COI in journals devoted to general and abdominal surgery. METHODS Information on publisher, definition of COI, whether COI disclosure was mandatory, publication of the disclosure statement with the article, and when publication of disclosure statements was introduced were gathered from instructions for authors and from journal editors and presented descriptively. The hypothesis that journals with a disclosure policy have greater impact factors was tested with a Wilcoxon rank-sum test. RESULTS A sample of 64 journals was investigated. In 8 journals (13%) disclosure was deemed unnecessary. In the remaining 56 journals (88%) disclosure of COI was mandatory and in 39 of these journals (61%) the COI statement was published with the article. Journals declaring COI disclosure as mandatory had a greater impact factor (0.626 vs 1.732; P = .006). CONCLUSION Transparency is critical to the reliability of evidence-based medicine. All efforts should be made to give the reader the maximum amount of information. We recommend that every surgeon maintain a standardized, up-to-date disclosure form.

Anti-angiogenic activity of VXM01, an oral T-cell vaccine against VEGF receptor 2, in patients with advanced pancreatic cancer: A randomized, placebo-controlled, phase 1 trial.

VEGFR-2 is expressed on tumor vasculature and a target for anti-angiogenic intervention. VXM01 is a first in kind orally applied tumor vaccine based on live, attenuated Salmonella bacteria carrying an expression plasmid, encoding VEGFR-2. We here studied the safety, tolerability, T effector (Teff), T regulatory (Treg) and humoral responses to VEGFR2 and anti-angiogenic effects in advanced pancreatic cancer patients in a randomized, dose escalation phase I clinical trial. Results of the first 3 mo observation period are reported. Locally advanced or metastatic, pancreatic cancer patients were enrolled. In five escalating dose groups, 30 patients received VXM01 and 15 placebo on days 1, 3, 5, and 7. Treatment was well tolerated at all dose levels. No dose-limiting toxicities were observed. Salmonella excretion and salmonella-specific humoral immune responses occurred in the two highest dose groups. VEGFR2 specific Teff, but not Treg responses were overall increased in vaccinated patients. We furthermore observed a significant reduction of tumor perfusion after 38 d in vaccinated patients together with increased levels of serum biomarkers indicative of anti-angiogenic activity, VEGF-A, and collagen IV. Vaccine specific Teff responses significantly correlated with reductions of tumor perfusion and high levels of preexisting VEGFR2-specific Teff while those showing no antiangiogenic activity had low levels of preexisting VEGFR2 specific Teff, showed a transient early increase of VEGFR2-specific Treg and reduced levels of VEGFR2-specific Teff at later time points – pointing to the possibility that early anti-angiogenic activity might be based at least in part on specific reactivation of preexisting memory T cells.

Duodenum-preserving pancreatic head resection: 10-year follow-up of a randomized controlled trial comparing the Beger procedure with the Berne modification

BACKGROUND Since the introduction of the duodenum-preserving pancreatic head resection for operative treatment of chronic pancreatitis, various modifications of the original Beger procedure have emerged. A randomized controlled trial comparing the Beger procedure and the Berne modification indicated that the latter is an equivalent alternative, but a comparison of the long-term results of both procedures has not yet been published. METHODS Between December 2002 and January 2005, 65 patients were randomized intraoperatively to the Beger or the Berne procedure. For this 10-year follow-up, patients were contacted by phone and in writing to evaluate patient-relevant outcome parameters. Statistical analysis was made on an intention-to-treat basis. RESULTS Median follow-up was 129 (111-137) months. Forty of 65 patients were available for follow-up; 11 of the original study cohort had died, and 14 were otherwise lost to follow-up. Quality of life, pain, occupational disability, exocrine and endocrine pancreatic function, endoscopic interventions, and redo operations were comparable in both groups. More than half of the patients were completely free of pain, and the majority in both groups judged that the index operation had improved their quality of life. CONCLUSION Ten-year follow-up showed no differences in patient-relevant outcome parameters between the Beger and Berne procedures for treatment of chronic pancreatitis. Because short-term results have shown the Berne modification is superior in terms of operation time and duration of hospital stay, it should be preferred whenever possible, depending on the individual surgeons expertise and the intraoperative findings.

Sphincter of Oddi botulinum toxin injection to prevent pancreatic fistula after distal pancreatectomy

Background. Postoperative pancreatic fistula represents the most important complication after distal pancreatectomy. The aim of this study was to evaluate the use of a preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi to prevent postoperative pancreatic fistula (German Clinical Trials Register number: DRKS00007885). Methods. This was an investigator‐initiated, prospective clinical phase I/II trial with an exploratory study design. We included patients who underwent preoperative endoscopic sphincter botulinum toxin injection (100 units of Botox). End points were the feasibility, safety, and postoperative outcomes, including postoperative pancreatic fistula within 30 days after distal pancreatectomy. Botulinum toxin patients were compared with a control collective of patients undergoing distal pancreatectomy without botulinum toxin injection by case‐control matching in a 1:1 ratio. Results. Between February 2015 and February 2016, 29 patients were included. All patients underwent successful sphincter of Oddi botulinum toxin injection within a median of 6 (range 0–10) days before operation. One patient had an asymptomatic, self‐limiting (48 hours) increase in serum amylase and lipase after injection. Distal pancreatectomy was performed in 24/29 patients; 5 patients were not resectable. Of the patients receiving botulinum toxin, 7 (29%) had increased amylase levels in drainage fluid on postoperative day 3 (the International Study Group of Pancreatic Surgery definition of postoperative pancreatic fistula grade A) without symptoms or need for reintervention. Importantly, no clinically relevant fistulas (International Study Group of Pancreatic Surgery grades B/C) were observed in botulinum toxin patients compared to 33% postoperative pancreatic fistula grade B/C in case‐control patients (P < .004). Conclusion. Preoperative sphincter of Oddi botulinum toxin injection is a novel and safe approach to decrease the incidence of clinically relevant postoperative pancreatic fistula after distal pancreatectomy. The results of the present trial suggest its efficacy in the prevention of clinically relevant postoperative pancreatic fistula and are validated currently in the German Federal Government–sponsored, multicenter, randomized controlled PREBOT trial.

Percutaneous versus surgical strategy for tracheostomy: protocol for a systematic review and meta-analysis of perioperative and postoperative complications

BackgroundTracheostomy is one of the most frequently performed procedures in intensive care medicine. The two main approaches to form a tracheostoma are the open surgical tracheotomy (ST) and the interventional strategy of percutaneous dilatational tracheotomy (PDT). It is particularly important to the critically ill patients that both procedures are performed with high success rates and low complication frequencies. Therefore, the aim of this systematic review is to summarize and analyze existing and relevant evidence for peri- and postoperative parameters of safety.Methods/designA systematic literature search will be conducted in The Cochrane Library, MEDLINE, LILACS, and Embase to identify all randomized controlled trials (RCTs) comparing peri- and postoperative complications between the two strategies and to define the strategy with the lower risk of potentially life-threatening events. A priori defined data will be extracted from included studies, and methodological quality will be assessed according to the recommendations of the Cochrane Collaboration.DiscussionThe findings of this systematic review with proportional meta-analysis will help to identify the strategy with the lowest frequency of potentially life-threatening events. This may influence daily practice, and the data may be implemented in treatment guidelines or serve as the basis for planning further randomized controlled trials. Considering the critical health of these patients, they will particularly benefit from evidence-based treatment.Systematic review registrationPROSPERO CRD42015021967

Meta‐analysis of immunonutrition in major abdominal surgery

The objective of this study was to evaluate the potential benefits of immunonutrition in major abdominal surgery with special regard to subgroups and influence of bias.

Meta-analysis of delayed gastric emptying after pylorus-preserving versus pylorus-resecting pancreatoduodenectomy.

Delayed gastric emptying (DGE) is a frequent complication after pylorus‐preserving pancreatoduodenectomy. Recent studies have suggested that resection of the pylorus is associated with decreased rates of DGE. However, superiority of pylorus‐resecting pancreatoduodenectomy was not shown in a recent RCT. This meta‐analysis summarized evidence of the effectiveness and safety of pylorus‐preserving compared with pylorus‐resecting pancreatoduodenectomy.

Pylorus preservation pancreatectomy or not

Pancreaticoduodenectomy (PD) is the treatment of choice for various benign and malignant tumors of the pancreatic head or the periampullary region, and the only hope for cure in patients with cancer at this side. While it has been associated with high morbidity and mortality rates in the last century, its centralization in specialized institutions together with refinements in the operative technique and better management of postoperative complications have made PD a standardized, safe procedure. Besides the classic Whipple procedure including distal gastrectomy, two variations of PD with or without pylorus resection, but preservation of the entire stomach in either procedure exist today. Pylorus-preserving PD has gained wide acceptance as standard procedure and is being performed by an increasing number of pancreatic surgeons. After its oncological adequacy was questioned initially, pylorus-preserving PD was shown to be equivalent to the classic Whipple procedure regarding tumor recurrence and long-term survival. Moreover, operation time and blood loss were shown to be reduced in the pylorus-preserving procedure and benefits in nutritional status and quality of life were observed. However, preservation of the pylorus has been suggested to result in an increased incidence of postoperative delayed gastric emptying (DGE). In this context, pylorus-resecting PD has become popular especially in Japan with the aim to prevent DGE by removal of the pylorus but preservation of the stomach. In contrast to positive results from early studies, latest high-quality randomized controlled trial (RCT) data show that pylorus resection does not reduce DGE compared to the pylorus-preserving operation. Non-superiority of pylorus resection was also confirmed in current meta-analysis on this topic. This article summarizes the existing evidence on PD with or without pylorus preservation and derives recommendations for daily practice.

Closed cannulation of subclavian vein vs open cut-down of cephalic vein for totally implantable venous access port (TIVAP) implantation: protocol for a systematic review and proportional meta-analysis of perioperative and postoperative complications

BackgroundTotally implantable venous access port (TIVAP) implantation is one of the most often performed operations in general surgery (over 100,000/year in Germany). The two main approaches for TIVAP placement are insertion into the cephalic vein through an open cut-down technique (OCD) or closed cannulation technique of the subclavian vein (CC) with Seldinger technique. Both procedures are performed with high success rates and very low complication frequencies. Because of the low incidence of complications, no single interventional trial is able to report a valid comparison of peri- and postoperative complication frequencies between both techniques. Therefore, the aim of this systematic review is to summarize evidence for peri- and postoperative complication rates in patients undergoing OCD or CC.Methods/DesignA systematic literature search will be conducted in The Cochrane Library, MEDLINE, and Embase to identify randomized controlled trials (RCTs), observational clinical studies (OCS), or case series (CS) reporting peri- and/or postoperative complications of at least one implantation technique. A priori defined data will be extracted from included studies, and methodological quality will be assessed. Event rates with their 95% confidence intervals will be derived taking into account the follow-up time per study by patient-months where appropriate. Pooled estimates of event rates with corresponding 95% confidence intervals will be calculated on the base of the Freeman-Tukey double arcsine transformation within a random effect model framework.DiscussionThe findings of this systematic review with proportional meta-analysis will help to identify the procedure with the best benefit/risk ratio for TIVAP implantation. This may have influence on daily practice, and data may be implemented in treatment guidelines. Considering the impact of TIVAP implantation on patients’ well being together with its socioeconomic relevance, patients will benefit from evidence-based treatment and health-care costs may also be reduced.Systematic review registrationPROSPERO CRD42013005180.