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The Cochrane Database of Systematic... May 2011Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple (CW) operation or a pylorus-preserving pancreaticoduodenectomy (PPW). It is unclear which of the procedures is more favourable in terms of survival, mortality, complications and quality of life.
OBJECTIVES
The objective of this systematic review is to compare the effectiveness of each operation.
SEARCH STRATEGY
We conducted searches on 28 March 2006 and 11 January 2011 to identify all randomised controlled trials (RCTs), applying no language restrictions. We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL), CDSR and DARE from The Cochrane Library (2010, Issue 4), MEDLINE (1966 to January 2011), and EMBASE (1980 to January 2011). Abstracts from Digestive Disease Week and U nited European Gastroenterology Week (1995 to 2010). No additional studies were indentified upon updating the systematic review in 2011.
SELECTION CRITERIA
We considered RCTs comparing the CW with PPW to be eligible if they included patients with periampullary or pancreatic carcinoma.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data from the included studies. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (OR), pooled continuous outcomes using mean differences (MD) and used hazard ratios (HR) for meta-analysis of survival. Two authors independently evaluated the methodological quality and risk of bias of the included studies according to Cochrane standards.
MAIN RESULTS
We included six randomised controlled trials with a total of 465 patients. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. In-hospital mortality (OR 0.49; 95% confidence interval (CI) 0.17 to 1.40; P = 0.18), overall survival (HR 0.84; 95% CI 0.61 to 1.16; P = 0.29) and morbidity showed no significant differences. However, we noted that operating time (MD -68.26 minutes; 95% CI -105.70 to -30.83; P = 0.0004) and intra-operative blood loss (MD -0.76 millilitres; 95% CI -0.96 to -0.56; P < 0.00001) were significantly reduced in the PPW group. All significant results have low quality of evidence based on GRADE criteria.
AUTHORS' CONCLUSIONS
There is no evidence of relevant differences in mortality, morbidity and survival between the two operations. Given obvious clinical and methodological heterogeneity, future research must be undertaken to perform high-quality randomised controlled trials of complex surgical interventions on the basis of well-defined outcome parameters.
Topics: Ampulla of Vater; Common Bile Duct Neoplasms; Gastric Emptying; Humans; Pancreatic Fistula; Pancreatic Neoplasms; Pancreaticoduodenectomy; Pylorus; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 21563148
DOI: 10.1002/14651858.CD006053.pub4 -
Pancreas 2019
Topics: Ampulla of Vater; Aneurysm, Ruptured; Endoscopy, Digestive System; Female; Gastrointestinal Hemorrhage; Humans; Male; Pancreatic Ducts; Splenic Artery; Tomography, X-Ray Computed
PubMed: 31090670
DOI: 10.1097/MPA.0000000000001278 -
The Cochrane Database of Systematic... Feb 2011Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple... (Review)
Review
WITHDRAWN: Pancreaticoduodenectomy (classic Whipple) versus pylorus-preserving pancreaticoduodenectomy (pp Whipple) for surgical treatment of periampullary and pancreatic carcinoma.
BACKGROUND
Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple operation or a pylorus-preserving pancreaticoduodenectomy. It is unclear which of the procedures is more favourable in terms of survival, mortality, complications and quality of life.
OBJECTIVES
Several publications have highlighted advantages and disadvantages of the two techniques and the current basis of evidence remains unclear. The objective of this systematic review is to compare the effectiveness of each operation.
SEARCH STRATEGY
We conducted a search on 28/03/2006 to identify all RCTs, applying no language restriction.We searched the following electronic databases: CENTRAL, CDSR and DARE from The Cochrane Library (2006, issue 2), MEDLINE (1966 to 2006) and EMBASE (1980 to 2006). We handsearched abstracts from 1995 to 2006 from the American Digestive Disease Week (DDW), published in Gastroenterology, and the United European Gastroenterology Week (UEGW), published in Gut.
SELECTION CRITERIA
We considered randomised controlled trials comparing the classic Whipple operation with pylorus-preserving pancreaticoduodenectomy to be eligible if they included patients with periampullary or pancreatic carcinoma.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data from the included studies. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (OR), pooled continuous outcomes using weighted mean differences (WMD), and used hazard ratios (HR) for meta-analysis of survival. Two authors independently evaluated the methodological quality of included studies according to quality standards and by using a questionnaire.
MAIN RESULTS
We retrieved 1235 abstracts and checked these for eligibility, including seven randomised controlled trials. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Our comparisons of in-hospital mortality (OR 0.49; 95% confidence interval (CI) 0.17 to 1.40; P = 0.18), overall survival (HR 0.84; 95% CI 0.61 to 1.16; P = 0.29) and morbidity showed no significant differences. However, we noted that operating time (WMD -68.26 minutes; 95% CI -105.70 to -30.83; P = 0.0004) and intra-operative blood loss (WMD -0.76 millilitres; 95% CI -0.96 to -0.56; P < 0.00001) were significantly reduced in the pylorus-preserving pancreaticoduodenectomy group.
AUTHORS' CONCLUSIONS
There is no evidence of relevant differences in mortality, morbidity and survival between the two operations. Given obvious clinical and methodological heterogeneity, future research must be undertaken to perform high-quality randomised controlled trials of complex surgical interventions on the basis of well-defined outcome parameters.
Topics: Ampulla of Vater; Common Bile Duct Neoplasms; Gastric Emptying; Humans; Pancreatic Neoplasms; Pancreaticoduodenectomy; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 21328281
DOI: 10.1002/14651858.CD006053.pub3 -
The Cochrane Database of Systematic... Oct 2014Endoscopic therapy reduces the rebleeding rate and the need for surgery in patients with bleeding peptic ulcers. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Endoscopic therapy reduces the rebleeding rate and the need for surgery in patients with bleeding peptic ulcers.
OBJECTIVES
To determine whether a second procedure improves haemostatic efficacy or patient outcomes or both after epinephrine injection in adults with high-risk bleeding ulcers.
SEARCH METHODS
For our update in 2014, we searched the following versions of these databases, limited from June 2009 to May 2014: Ovid MEDLINE(R) 1946 to May Week 2 2014; Ovid MEDLINE(R) Daily Update May 22, 2014; Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations May 22, 2014 (Appendix 1); Evidence-Based Medicine (EBM) Reviews-the Cochrane Central Register of Controlled Trials (CENTRAL) April 2014 (Appendix 2); and EMBASE 1980 to Week 20 2014 (Appendix 3).
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing epinephrine alone versus epinephrine plus a second method. Populations consisted of patients with high-risk bleeding peptic ulcers, that is, patients with haemorrhage from peptic ulcer disease (gastric or duodenal) with major stigmata of bleeding as defined by Forrest classification Ia (spurting haemorrhage), Ib (oozing haemorrhage), IIa (non-bleeding visible vessel) and IIb (adherent clot) (Forrest Ia-Ib-IIa-IIb).
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as expected by The Cochrane Collaboration. Meta-analysis was undertaken using a random-effects model; risk ratios (RRs) with 95% confidence intervals (CIs) are presented for dichotomous data.
MAIN RESULTS
Nineteen studies of 2033 initially randomly assigned participants were included, of which 11 used a second injected agent, five used a mechanical method (haemoclips) and three employed thermal methods.The risk of further bleeding after initial haemostasis was lower in the combination therapy groups than in the epinephrine alone group, regardless of which second procedure was applied (RR 0.53, 95% CI 0.35 to 0.81). Adding any second procedure significantly reduced the overall bleeding rate (persistent and recurrent bleeding) (RR 0.57, 95% CI 0.43 to 0.76) and the need for emergency surgery (RR 0.68, 95% CI 0.50 to 0.93). Mortality rates were not significantly different when either method was applied.Rebleeding in the 10 studies that scheduled a reendoscopy showed no difference between epinephrine and combined therapy; without second-look endoscopy, a statistically significant difference was observed between epinephrine and epinephrine and any second endoscopic method, with fewer participants rebleeding in the combined therapy group (nine studies) (RR 0.32, 95% CI 0.21 to 0.48).For ulcers of the Forrest Ia or Ib type (oozing or spurting), the addition of a second therapy significantly reduced the rebleeding rate (RR 0.66, 95% CI 0.49 to 0.88); this difference was not seen for type IIa (visible vessel) or type IIb (adherent clot) ulcers. Few procedure-related adverse effects were reported, and this finding was not statistically significantly different between groups. Few adverse events occurred, and no statistically significant difference was noted between groups.The addition of a second injected method reduced recurrent and persistent rebleeding rates and surgery rates in the combination therapy group, but these findings were not statistically significantly different. Significantly fewer participants died in the combined therapy group (RR 0.50, 95% CI 0.25 to 1.00).Epinephrine and a second mechanical method decreased recurrent and persistent bleeding (RR 0.31, 95% CI 0.18 to 0.54) and the need for emergency surgery (RR 0.20, 95% CI 0.06 to 0.62) but did not affect mortality rates.Epinephrine plus thermal methods decreased the rebleeding rate (RR 0.49, 95% CI 0.30 to 0.78) and the surgery rate (RR 0.20, 95% CI 0.06 to 0.62) but did not affect the mortality rate.Our risk of bias estimates show that risk of bias was low, as, although the type of study did not allow a double-blind trial, rebleeding, surgery and mortality were not dependent on subjective observation. Although some studies had limitations in their design or implementation, most were clear about important quality criteria, including randomisation and allocation concealment, sequence generation and blinding.
AUTHORS' CONCLUSIONS
Additional endoscopic treatment after epinephrine injection reduces further bleeding and the need for surgery in patients with high-risk bleeding peptic ulcer. The main adverse events include risk of perforation and gastric wall necrosis, the rates of which were low in our included studies and favoured neither epinephrine therapy nor combination therapy. The main conclusion is that combined therapy seems to work better than epinephrine alone. However, we cannot conclude that a particular form of treatment is equal or superior to another.
Topics: Adult; Combined Modality Therapy; Epinephrine; Hemostasis, Endoscopic; Humans; Peptic Ulcer Hemorrhage; Randomized Controlled Trials as Topic; Secondary Prevention; Vasoconstrictor Agents
PubMed: 25308912
DOI: 10.1002/14651858.CD005584.pub3 -
Archives of Internal Medicine Jul 2000In the last decades, studies have estimated the upper gastrointestinal tract bleeding/perforation (UGIB) risk associated with individual nonsteroidal anti-inflammatory... (Review)
Review
Association between nonsteroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation: an overview of epidemiologic studies published in the 1990s.
BACKGROUND
In the last decades, studies have estimated the upper gastrointestinal tract bleeding/perforation (UGIB) risk associated with individual nonsteroidal anti-inflammatory drugs (NSAIDs). Later analyses have also included the effect of patterns of NSAID use, risk factors for UGIB, and modifiers of NSAID effect.
METHODS
Systematic review of case-control and cohort studies on serious gastrointestinal tract complications and nonaspirin NSAIDs published between 1990 and 1999 using MEDLINE. Eighteen original studies were selected according to predefined criteria. Two researchers extracted the data independently. Pooled relative risk estimates were calculated according to subject and exposure characteristics. Heterogeneity of effects was tested and reasons for heterogeneity were considered.
RESULTS
Advanced age, history of peptic ulcer disease, and being male were risk factors for UGIB. Nonsteroidal anti-inflammatory drug users with advanced age or a history of peptic ulcer had the highest absolute risks. The pooled relative risk of UGIB after exposure to NSAIDs was 3.8 (95% confidence interval, 3.6-4.1). The increased risk was maintained during treatment and returned to baseline once treatment was stopped. A clear dose response was observed. There was some variation in risk between individual NSAIDs, though these differences were markedly attenuated when comparable daily doses were considered.
CONCLUSIONS
The elderly and patients with a history of peptic ulcer could benefit the most from a reduction in NSAID gastrotoxicity. Whenever possible, physicians may wish to recommend lower doses to reduce the UGIB risk associated with all individual NSAIDs, especially in the subgroup of patients with the greatest background risk.
Topics: Age Factors; Anti-Inflammatory Agents, Non-Steroidal; Duodenal Ulcer; Epidemiologic Studies; Gastrointestinal Hemorrhage; Humans; Incidence; Peptic Ulcer Perforation; Risk Factors; Sex Factors; Stomach Ulcer
PubMed: 10904451
DOI: 10.1001/archinte.160.14.2093 -
Digestive Diseases and Sciences Sep 2019In cases of difficult biliary cannulation, transpancreatic sphincterotomy (TPS) can be an alternative approach of biliary access. However, its success and safety profile... (Comparative Study)
Comparative Study Meta-Analysis
In cases of difficult biliary cannulation, transpancreatic sphincterotomy (TPS) can be an alternative approach of biliary access. However, its success and safety profile have not been studied in detail. A systematic review and meta-analysis were performed to study the overall cannulation success and adverse events of TPS. These outcomes were also compared to other advanced cannulation methods. A systematic literature search was conducted to find all relevant articles containing data on TPS. Successful biliary cannulation and complications rates [post-ERCP pancreatitis (PEP), bleeding, and perforation rates] were compared in the pooled analyses of prospective comparative studies. The overall outcomes were calculated involving all studies on TPS. TPS was superior compared to needle-knife precut papillotomy (NKPP) and the double-guidewire method (DGW) regarding cannulation success (odds ratio [OR] 2.32; 95% confidence interval [CI] 1.37-3.93; and OR 2.72; 95% CI 1.30-5.69, respectively). The rate of PEP did not differ between TPS and NKPP or DGW; however, TPS (only retrospective studies were available for comparison) proved to be worse than needle-knife fistulotomy in this regard (OR 4.62; 95% CI 1.36-15.72). Bleeding and perforation rates were similar among these advanced techniques. There were no data about long-term consequences of TPS. The biliary cannulation rate of TPS is higher than that of the other advanced cannulation techniques, while the safety profile is similar to those. However, no long-term follow-up studies are available on the later consequences of TPS; therefore, such studies are strongly needed for its full evaluation.
Topics: Ampulla of Vater; Biliary Tract; Catheterization; Cholangiopancreatography, Endoscopic Retrograde; Clinical Competence; Humans; Pancreatic Ducts; Pancreatitis; Postoperative Hemorrhage; Sphincterotomy, Endoscopic; Time Factors
PubMed: 31055720
DOI: 10.1007/s10620-019-05640-4 -
Journal of Ethnopharmacology Nov 2021Different orchids are important in traditional medicine, and species belonging to the genus Bletilla are important. Bletilla species have been used for thousands of...
ETHNOPHARMACOLOGICAL RELEVANCE
Different orchids are important in traditional medicine, and species belonging to the genus Bletilla are important. Bletilla species have been used for thousands of years in Traditional Chinese Medicine (TCM) for the treatment of several health disorders, such as gastrointestinal disorders, peptic ulcer, lung disorders, and traumatic bleeding etc. AIM OF THIS REVIEW: This review aims to provide a systematic overview and objective analysis of Bletilla species and to find the probable relationship between their traditional use, chemical constituents, and pharmacological activities, while assessing their therapeutic potential in treatment of different human diseases.
MATERIALS AND METHODS
Relevant literatures on Bletilla species have been collected using the keywords "Bletilla", "phytochemistry", and "pharmacology" in scientific databases, such as "PubMed", "Scifinder", "The Plant List", "Elsevier", "China Knowledge Resource Integrated databases (CNKI)", "Google Scholar", "Baidu Scholar", and other literature sources, etc. RESULTS: This review indicates the isolation and identification of over 261 compounds from this genus, till December 2020. These chemical isolates belong to the stilbenes (bibenzyls and phenanthrenes), flavonoids, triterpenoids, steroids, simple phenolics, and glucosyloxybenzyl 2-isobutylmalates classes of compounds. These compounds have been reported to be characteristically distributed in Bletilla striata (Thunb.) Rchb. f. (BS), Bletilla ochracea Schltr. (BO), and Bletilla formosana (Hayata) Schltr. (BF). The crude extracts and pure compounds derived from the three Bletilla species have reportedly exhibited a wide spectrum of in vitro and in vivo pharmacological effects, such as hemostatic, anti-inflammatory, anti-tumor, and anti-microbial activities. As a Traditional Chinese Medicine (TCM), Bletilla species or preparations containing Bletilla species have been used for the treatment of epistaxis, gastrointestinal bleeding, cough and hemoptysis, gastric and duodenal ulcer, and traumatic injuries. Thus, Bletilla species have proven potential both in traditional uses and scientific studies.
CONCLUSIONS
Pharmacological studies have validated the use of Bletilla species in the traditional medicine, especially hemorrhagic diseases. Polysaccharides and stilbenes are the major bioactive chemical constituents of Bletilla genus according to the literatures. However, the mechanism of action of these molecules is yet to be studied. In addition, a detailed comparative analysis of the phytochemistry and biological activities of the three Bletilla species (BS, BO and BF) is highly recommended for understanding their ethnopharmacological uses and applications in clinics. Clinical toxicity tests on BS have been found to be negative, but it can't be used with Aconitum carmichaeli in traditional uses. Furthermore, not many reports are present in the literature regarding the conservation of Bletilla species.
Topics: Animals; Drugs, Chinese Herbal; Ethnopharmacology; Humans; Medicine, Chinese Traditional; Orchidaceae; Phytochemicals; Polysaccharides; Stilbenes
PubMed: 34144194
DOI: 10.1016/j.jep.2021.114263 -
Digestive Diseases and Sciences Aug 2019Endoscopic biliary sphincterotomy (EST) is commonly performed during therapeutic endoscopic retrograde cholangiopancreatography (ERCP), but is an independent risk factor... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIMS
Endoscopic biliary sphincterotomy (EST) is commonly performed during therapeutic endoscopic retrograde cholangiopancreatography (ERCP), but is an independent risk factor for post-ERCP pancreatitis, bleeding and duodenal perforation. These are partly ascribed to the electrosurgical current mode used for EST, and currently the optimal current model for EST remains controversial. In this study, we aimed to compare the rate of complications undergoing EST using the Endocut versus the blended current.
METHODS
A systematic search of databases was performed for relevant published and prospective studies including randomized clinical trials (RCTs) to compare Endocut with blended current modes for EST. Data were collected from inception until 1 July 2018, using post-ERCP pancreatitis, bleeding and perforation as primary outcomes.
RESULTS
Three RCTs including a total of 594 patients met the inclusion criteria. Our meta-analysis results showed the rate of post-ERCP pancreatitis, primarily mild to moderate pancreatitis, was no different between Endocut versus blended current modes [risk ratio (RR) 0.61, 95% confidence interval (CI) 0.25-1.52, P = 0.29]. However, the risk of endoscopically bleeding events, primarily mild bleeding, was lower in studies using Endocut versus blended current (RR 0.54, 95% CI 0.31-0.95, P = 0.03). Notably, none of the patients experienced perforation in these three trials.
CONCLUSIONS
The rate of post-ERCP pancreatitis was not significantly different when using the Endocut versus blended current during EST. Nevertheless, compared with the blended current, Endocut reduced the incidence of endoscopically evident bleeding; however, the available data were insufficient to assess the perforation risk.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Duodenal Diseases; Electrosurgery; Humans; Intestinal Perforation; Pancreatitis; Postoperative Hemorrhage; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sphincterotomy, Endoscopic; Treatment Outcome
PubMed: 30778871
DOI: 10.1007/s10620-019-05513-w -
The Cochrane Database of Systematic... Apr 2008Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple... (Review)
Review
BACKGROUND
Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple operation or a pylorus-preserving pancreaticoduodenectomy but it is still unclear which of the two procedures is more favourable in terms of survival, mortality, complications, perioperative factors and quality of life.
OBJECTIVES
Several publications pointed out both advantages and disadvantages of both techniques and the current basis of evidence remains unclear. The objective of this systematic review is to compare the effectiveness of each technique.
SEARCH STRATEGY
A search was conducted to identify all published and unpublished randomised controlled trials. Trials were identified by searching the following electronic databases - The Cochrane Library, MEDLINE, EMBASE and Current Contents. Reference lists from trials selected by electronic searching were hand-searched to identify further relevant trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing the classical Whipple (CW) with the pylorus-preserving pancreaticoduodenectomy (PPW) were considered eligible if patients with periampullary or pancreatic carcinoma were included.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data for included studies. A random-effects model was used for pooling data from the different trials. Binary outcomes were compared using odds ratios, continuous outcomes were pooled using weighted mean differences and hazard ratios were used to for the meta-analysis of survival data. The methodological quality of included studies was evaluated independently by two authors according to quality standards and by using a questionnaire that covers different aspects of quality.
MAIN RESULTS
1235 abstracts were retrieved and checked for eligibility and seven RCTs were finally included. The critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. The comparison of overall in-hospital mortality (odds ratio 0.49; 95% CI 0.17 to 1.40; P=0.18), overall survival (hazard ratio 0.84; 95% CI 0.61 to 1.16; P=0.29) and morbidity showed no significant difference. However, operating time (weighted mean difference -68.26 min; 95% CI -105.70 to -30.83; P=0.0004) and intra-operative blood loss (weighted mean difference -0.76 ml; 95% CI -0.96 to -0.56; P<0.00001) were significantly reduced in the PPW group.
AUTHORS' CONCLUSIONS
There is no evidence of relevant differences in mortality, morbidity and survival between the PPW and the CW. Given obvious clinical and methodological inter-study heterogeneity, future efforts have to be undertaken to perform high quality RCTs of complex surgical interventions on the basis of well defined outcome parameters.
Topics: Ampulla of Vater; Common Bile Duct Neoplasms; Gastric Emptying; Humans; Pancreatic Neoplasms; Pancreaticoduodenectomy; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 18425935
DOI: 10.1002/14651858.CD006053.pub2 -
The Cochrane Database of Systematic... Jan 2021Pancreatic and periampullary adenocarcinomas account for some of the most aggressive malignancies, and the leading causes of cancer-related mortalities. Partial... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pancreatic and periampullary adenocarcinomas account for some of the most aggressive malignancies, and the leading causes of cancer-related mortalities. Partial pancreaticoduodenectomy (PD) with negative resection margins is the only potentially curative therapy. The high prevalence of lymph node metastases has led to the hypothesis that wider excision with the removal of more lymphatic tissue could result in an improvement of survival, and higher rates of negative resection margins.
OBJECTIVES
To compare overall survival following standard (SLA) versus extended lymph lymphadenectomy (ELA) for pancreatic head and periampullary adenocarcinoma. We also compared secondary outcomes, such as morbidity, mortality, and tumour involvement of the resection margins between the two procedures.
SEARCH METHODS
We searched CENTRAL, MEDLINE, PubMed, and Embase from 1973 to September 2020; we applied no language restrictions.
SELECTION CRITERIA
Randomised controlled trials (RCT) comparing PD with SLA versus PD with ELA, including participants with pancreatic head and periampullary adenocarcinoma.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened references and extracted data from study reports. We calculated pooled risk ratios (RR) for most binary outcomes except for postoperative mortality, for which we estimated a Peto odds ratio (Peto OR), and mean differences (MD) for continuous outcomes. We used a fixed-effect model in the absence of substantial heterogeneity (I² < 25%), and a random-effects model in cases of substantial heterogeneity (I² > 25%). Two review authors independently assessed risk of bias, and we used GRADE to assess the quality of the evidence for important outcomes.
MAIN RESULTS
We included seven studies with 843 participants (421 ELA and 422 SLA). All seven studies included Kaplan-Meier curves for overall survival. There was little or no difference in survival between groups (log hazard ratio (log HR) 0.12, 95% confidence interval (CI) -3.06 to 3.31; P = 0.94; seven studies, 843 participants; very low-quality evidence). There was little or no difference in postoperative mortality between the groups (Peto odds ratio (OR) 1.20, 95% CI 0.51 to 2.80; seven studies, 843 participants; low-quality evidence). Operating time was probably longer for ELA (mean difference (MD) 50.13 minutes, 95% CI 19.19 to 81.06 minutes; five studies, 670 participants; moderate-quality evidence). There was substantial heterogeneity between the studies (I² = 88%; P < 0.00001). There may have been more blood loss during ELA (MD 137.43 mL, 95% CI 11.55 to 263.30 mL; two studies, 463 participants; very low-quality evidence). There was substantial heterogeneity between the studies (I² = 81%, P = 0.02). There may have been more lymph nodes retrieved during ELA (MD 11.09 nodes, 95% CI 7.16 to 15.02; five studies, 670 participants; moderate-quality evidence). There was substantial heterogeneity between the studies (I² = 81%, P < 0.00001). There was little or no difference in the incidence of positive resection margins between groups (RR 0.81, 95% CI 0.58 to 1.13; six studies, 783 participants; very low-quality evidence).
AUTHORS' CONCLUSIONS
There is no evidence of an impact on survival with extended versus standard lymph node resection. However, the operating time may have been longer and blood loss greater in the extended resection group. In conclusion, current evidence neither supports nor refutes the effect of extended lymph lymphadenectomy in people with adenocarcinoma of the head of the pancreas.
Topics: Adenocarcinoma; Adult; Ampulla of Vater; Blood Loss, Surgical; Common Bile Duct Neoplasms; Confidence Intervals; Gastric Emptying; Humans; Kaplan-Meier Estimate; Lymph Node Excision; Margins of Excision; Operative Time; Pancreatic Fistula; Pancreatic Neoplasms; Pancreaticoduodenectomy; Postoperative Complications; Postoperative Hemorrhage; Randomized Controlled Trials as Topic
PubMed: 33471373
DOI: 10.1002/14651858.CD011490.pub2