Benefits of Prokinetics, Gastroparesis Diet, or Neuromodulators Alone or in Combination for Symptoms of Gastroparesis.

BACKGROUND & AIMS: Prokinetics have limited effectiveness for treating symptoms of gastroparesis. Thus, alternative or adjunct therapies, such as gastroparesis diets or neuromodulators, are often prescribed. Their therapeutic benefits alone or in combination remain unclear. METHODS: One hundred and twenty-nine patients with symptoms of gastroparesis underwent wireless motility capsule gastric emptying time and gastric emptying scintigraphy. Based on test results, changes in therapy were recommended. Changes in Gastroparesis Cardinal Symptom Index (GCSI) and individual symptom scores over 6 months were related to recommendations for prokinetics, gastroparesis diet, or neuromodulators given as solo new therapies or in dual combinations. Multivariate analyses were performed to adjust for gastric emptying and other variables. RESULTS: In the whole group regardless of therapy, GCSI scores decreased by 0.53 points (interquartile range, -1.25 to 0.05; P < .0001) over 6 months. GCSI did not decrease for prokinetics as solo new therapy (P = .95). Conversely, neuromodulators as solo therapy decreased GCSI scores (P = .04) and all individual symptoms except nausea/vomiting (P = .86). Prokinetics combined with gastroparesis diets or neuromodulators improved GCSI scores (P ≤ .04) and most individual symptoms. Adjusting for gastric emptying time on multivariate analyses showed greater GCSI decreases for nondelayed emptying for neuromodulators as solo new therapy (P = .01). Gastric emptying scintigraphy, gender, diabetes, and functional dyspepsia did not influence responses to any treatment. CONCLUSIONS: Initiating prokinetics as solo new therapy had little benefit for patients with symptoms of gastroparesis. Neuromodulators as the only new therapy decreased symptoms other than nausea and vomiting, especially with nondelayed gastric emptying. Adding gastroparesis diets or neuromodulators to prokinetics offered relief, suggesting that combination therapies may be more useful in managing these patients. (ClinicalTrials.gov NCT02022826.).

AGA Clinical Practice Update on Gastric Peroral Endoscopic Myotomy for Gastroparesis: Commentary.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert advice regarding cognitive, procedural, and post-procedural aspects of performing gastric peroral endoscopic myotomy for the treatment of refractory gastroparesis. METHODS: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors who are advanced endoscopists with expertise in treating patients by performing third-space endoscopy and gastric peroral endoscopic myotomy.

Effect and mechanism of needleless transcutaneous neuromodulation on gastrointestinal function after pancreaticoduodenectomy.

BACKGROUND: Gastrointestinal motility disorders tend to develop after pancreaticoduodenectomy (PD). The objectives of this study were: (1) to investigate the impact of needleless transcutaneous neuromodulation (TN) on the postoperative recuperation following pancreaticoduodenectomy (PD), and (2) to explore the underlying mechanisms by which TN facilitates the recovery of gastrointestinal function after PD. METHODS: A total of 41 patients scheduled for PD were randomized into two groups: the TN group (n = 21) and the Sham-TN group (n = 20). TN was performed at acupoints ST-36 and PC-6 twice daily for 1 h from the postoperative day 1 (POD1) to day 7. Sham-TN was performed at non-acupoints. Subsequent assessments incorporated both heart rate variation and dynamic electrogastrography to quantify alterations in vagal activity (HF) and gastric pacing activity. RESULTS: 1)TN significantly decreased the duration of the first passage of flatus (p < 0.001) and defecation (p < 0.01) as well as the time required to resume diet (p < 0.001) when compared to sham-TN;2)Compared with sham-TN, TN increased the proportion of regular gastric pacing activity (p < 0.01);3) From POD1 to POD7, there was a discernible augmentation in HF induced by TN stimulation(p < 0.01);4) TN significantly decreased serum IL-6 levels from POD1 to POD7 (p < 0.001);5) TN was an independent predictor of shortened hospital stay(ß = - 0.349, p = 0.035). CONCLUSION: Needleless TN accelerates the recovery of gastrointestinal function and reduces the risk of delayed gastric emptying in patients after PD by enhancing vagal activity and controlling the inflammatory response.

The impact of delayed gastric emptying as measured by gastric emptying scintigraphy on the outcome of magnetic sphincter augmentation.

INTRODUCTION: The impact of delayed gastric emptying (DGE) on the outcome of anti-reflux surgery (ARS) is controversial. There is concern that poor gastric emptying diminishes outcomes. Magnetic sphincter augmentation (MSA) may have a comparatively mild impact on gastric physiology, but the relationship between DGE and MSA outcomes is unknown. This study aims to evaluate the relationship between objective DGE and MSA outcomes over time. METHODS: Patients who completed gastric emptying scintigraphy (GES) prior to MSA between 2013 and 2021 were included. DGE was defined as a 4 h retention > 10% or half emptying time > 90 min on GES. Outcomes were compared between DGE and normal gastric emptying (NGE) groups at 6 months, 1 and 2 years. Sub-analysis of patients with severe (> 35%) DGE and correlation analysis between 4-h retention and symptom and acid-normalization were performed. RESULTS: The study population consisted of 26 (19.8%) patients with DGE and 105 with NGE. DGE was associated with more 90-days readmissions (18.5 vs 2.9%, p = 0.009). At 6 months patients with DGE had higher median (IQR) GERD-HRQL total [17.0(10-29) vs 5.5(3-16), p = 0.0013], heartburn [1(1-3) vs 0(0-1), p = 0.0010) and gas-bloat [4(2-5) vs 2(1-3), p = 0.033] scores. Outcomes at 1 and 2 years follow-up were comparable (p > 0.05). From 6 months to 1-year the gas-bloat score decreased from 4(2-5) to 3(1-3), p = 0.041. Total and heartburn scores decreased, but not significantly. Severe DGE (n = 4) patients had lower antiacid medication freedom at 6 months (75 vs 87%, p = 0.014) and 1-year (50 vs 92%, p = 0.046). There were non-significant trends for higher GERD-HRQL scores, dissatisfaction, and removal rates in severe DGE at 6 months and 1-year. There was a weak correlation between 4-h retention and 6-month GERD-HRQL total score [R = 0.253, 95%CI (0.09-0.41), p = 0.039], but not acid-normalization (p > 0.05). CONCLUSION: Outcomes after MSA are diminished early on in patients with mild-to-moderate DGE, but comparable by 1 year and durable at 2 years. Severe DGE outcomes may be suboptimal.

Significant changes in impedance planimetry (EndoFLIP™) measurements after peroral pyloromyotomy for delayed gastric emptying.

BACKGROUND: The endoluminal functional lumen imaging probe (FLIP) can be used to obtain real-time measurements of the diameter (Dmin), cross-sectional area (CSA), and distensibility of the pylorus before and after peroral pyloromyotomy (POP), an emerging endoscopic treatment for delayed gastric emptying. Our study aims to report our single-center experience in performing POP with FLIP measurements before and after pyloromyotomy. METHODS: A retrospective review of a prospectively maintained gastroesophageal database was performed. Demographic and perioperative data, including intraoperative FLIP measurements of the pylorus before and after POP, were analyzed. Measurements were compared using paired t tests. RESULTS: Thirty-four patients underwent POP between February 2017 and July 2020. Twenty-three (67.7%) patients were male and the average age was 59 years. The etiology of delayed gastric emptying was post-vagotomy in 22 patients, idiopathic gastroparesis in 7 patients, and diabetic gastroparesis in 5 patients. There were no significant differences in pre-myotomy or post-myotomy FLIP measurements when comparing the post-vagotomy versus the gastroparesis groups. There were significant increases in Dmin, CSA, and distensibility index when comparing pre-myotomy and post-myotomy readings for all patients (all p < 0.001). At follow-up, 64.7% of patients reported resolution of all symptoms. CONCLUSION: POP is an effective intervention in patients with delayed gastric emptying. Significant changes in FLIP measurements before and after POP suggest that FLIP may be a useful adjunct in guiding the management of delayed gastric emptying.

Transient delayed gastric emptying following laparoscopic Nissen fundoplication for gastroesophageal reflux disease.

PURPOSE: Although laparoscopic Nissen fundoplication (LNF) is a kind of minimally invasive surgery, some transition time may still be required to allow the fundoplicated stomach to adapt to the new anatomical position. We observed transient delayed gastric emptying (DGE) post-LNF in our preliminary study. This study aimed to investigate the occurrence rate and development of transient DGE post-LNF. METHODS: Patients who underwent LNF for gastroesophageal reflux disease (GERD) at our institution were recruited consecutively. They were treated with standardized LNF and prospectively followed up for 2 months. Proper diet guidance and/or pharmacologic therapy were given during these 2 months. GERD Health-Related Quality of Life (GERD-HRQL), DGE symptoms, and DGE status were evaluated preoperatively and postoperatively. RESULTS: Fifty-one patients underwent LNF and completed a 2-month follow-up. LNF succeeded in all patients. Prior to LNF, no DGE was identified. At the 1-month follow-up, LNF led to a significant reduction in the GERD-HRQL total score but a significantly increased DGE score. Endoscopically, DGE was identified in forty-seven (n = 47, 92.2%) patients. At the 2-month follow-up, the GERD-HRQL scores continued to show decreases compared to the 1 month. The DGE score returned to the baseline value. Endoscopically, no DGE was identified in any patients (n = 0, 0.0%). CONCLUSIONS: Transient DGE is a very common one-month post-LNF but can recover quickly in the second month following LNF.

Functional syndromes and symptom-orientated aftercare after esophagectomy.

BACKGROUND: Surgery is the cornerstone of esophageal cancer treatment but remains burdened with significant postoperative changes of gastrointestinal function and quality of life. PURPOSE: The aim of this narrative review is to assess and summarize the current knowledge on postoperative functional syndromes and quality of life after esophagectomy for cancer, and to provide orientation for the reader in the challenging field of functional aftercare. CONCLUSIONS: Post-esophagectomy syndromes include various conditions such as dysphagia, reflux, delayed gastric emptying, dumping syndrome, weight loss, and chronic diarrhea. Clinical pictures and individual expressions are highly variable and may be extremely distressing for those affected. Therefore, in addition to a mostly well-coordinated oncological follow-up, we strongly emphasize the need for regular monitoring of physical well-being and gastrointestinal function. The prerequisite for an effective functional aftercare covering the whole spectrum of postoperative syndromes is a comprehensive knowledge of the pathophysiological background. As functional conditions often require a complex diagnostic workup and long-term therapy, close interdisciplinary cooperation with radiologists, gastroenterologists, oncologists, and specialized nutritional counseling is imperative for successful management.

Gastrointestinal Uses of Botulinum Toxin.

Botulinum toxin (BT), one of the most powerful inhibitors that prevents the release of acetylcholine from nerve endings, represents an alternative therapeutic approach for "spastic" disorders of the gastrointestinal tract such as achalasia, gastroparesis, sphincter of Oddi dysfunction, chronic anal fissures, and pelvic floor dyssynergia.BT has proven to be safe and this allows it to be a valid alternative in patients at high risk of invasive procedures but long-term efficacy in many disorders has not been observed, primarily due to its relatively short duration of action. Administration of BT has a low rate of adverse reactions and complications. However, not all patients respond to BT therapy, and large randomized controlled trials are lacking for many conditions commonly treated with BT.The local injection of BT in some conditions becomes a useful tool to decide to switch to more invasive therapies. Since 1980, the toxin has rapidly transformed from lethal poison to a safe therapeutic agent, with a significant impact on the quality of life.

Diagnostic criteria and symptom grading for delayed gastric conduit emptying after esophagectomy for cancer: international expert consensus based on a modified Delphi process.

Delayed gastric conduit emptying (DGCE) after esophagectomy for cancer is associated with adverse outcomes and troubling symptoms. Widely accepted diagnostic criteria and a symptom grading tool for DGCE are missing. This hampers the interpretation and comparison of studies. A modified Delphi process, using repeated web-based questionnaires, combined with live interim group discussions was conducted by 33 experts within the field, from Europe, North America, and Asia. DGCE was divided into early DGCE if present within 14 days of surgery and late if present later than 14 days after surgery. The final criteria for early DGCE, accepted by 25 of 27 (93%) experts, were as follows: >500 mL diurnal nasogastric tube output measured on the morning of postoperative day 5 or later or >100% increased gastric tube width on frontal chest x-ray projection together with the presence of an air-fluid level. The final criteria for late DGCE accepted by 89% of the experts were as follows: the patient should have 'quite a bit' or 'very much' of at least two of the following symptoms; early satiety/fullness, vomiting, nausea, regurgitation or inability to meet caloric need by oral intake and delayed contrast passage on upper gastrointestinal water-soluble contrast radiogram or on timed barium swallow. A symptom grading tool for late DGCE was constructed grading each symptom as: 'not at all', 'a little', 'quite a bit', or 'very much', generating 0, 1, 2, or 3 points, respectively. For the five symptoms retained in the diagnostic criteria for late DGCE, the minimum score would be 0, and the maximum score would be 15. The final symptom grading tool for late DGCE was accepted by 27 of 31 (87%) experts. For the first time, diagnostic criteria for early and late DGCE and a symptom grading tool for late DGCE are available, based on an international expert consensus process.

Therapeutic effect of a temporary transpyloric stent in refractory post-surgical gastroparesis: a case report.

BACKGROUND: Gastroparesis is a syndrome characterized by delayed gastric emptying with associated symptoms. It was reported that the symptoms of diabetic gastroparesis had been greatly improved by transpyloric stent placement. However, the use of stents in benign conditions is considered to be contraindicated because of the increasing risk of complications, such as stent migration, reflux, perforation, bleeding, and, most importantly, new strictures caused by stent-induced tissue hyperplasia. While temporary placement of a self-expanding metallic stent (SEMC) can drastically reduce the risk of complications, few reports are available on the treatment of refractory PSG by temporary transpyloric stent. Does it have a long-term clinical effect after the stent being retrieved? CASE PRESENTATION: After accepting partial resection of the lesser curvature in another hospital, a patient developed refractory gastroparesis. The symptoms hadn't been improved after long-term drug therapy and balloon dilation therapy. Four months after surgery, a fully covered SEMC was placed by endoscopy in our hospital. Gastroparesis had been greatly improved. Two weeks later, the transpyloric stent was retrieved and the patient didn't show recurrent symptoms. Follow-ups were arranged at 3 months, 6 months and 1 year respectively, and there was no evidence of recurrence was found. CONCLUSIONS: This case indicates that temporary transpyloric SEMC is a safe, effective and less invasive alternative for post-surgical gastroparesis patients.

Braun anastomosis lowers the incidence of delayed gastric emptying following pancreaticoduodenectomy: a meta-analysis.

BACKGROUND: Delayed gastric emptying (DGE) is one of the most frequent complications following pancreaticoduodenectomy. This meta-analysis aimed to evaluate the impact of Braun enteroenterostomy on DGE following pancreaticoduodenectomy. METHODS: A systematic review of the literature was performed to identify relevant studies. Statistical analysis was carried out using Review Manager software 5.3. RESULTS: Eleven studies involving 1672 patients (1005 in Braun group and 667 in non-Braun group) were included in the meta-analysis. Braun enteroenterostomy was associated with a statistically significant reduction in overall DGE (odds ratios [OR] 0.32, 95% confidence intervals [CI] 0.24 to 0.43; P <0.001), clinically significant DGE (OR 0.27, 95% CI 0.15 to 0.51; P <0.001), bile leak (OR 0.50, 95% CI 0.29 to 0.86; P = 0.01), and length of hospital stay (weighted mean difference -1.66, 95% CI -2.95 to 00.37; P = 0.01). CONCLUSIONS: Braun enteroenterostomy minimizes the rate and severity of DGE following pancreaticoduodenectomy.

Preoperative fasting in children: review of existing guidelines and recent developments.

The current guidelines for preoperative fasting recommend intervals of 6, 4, and 2 h (6-4-2) of fasting for solids, breast milk, and clear fluids, respectively. The objective is to minimize the risk of pulmonary aspiration of gastric contents, but also to prevent unnecessarily long fasting intervals. Pulmonary aspiration is rare and associated with nearly no mortality in paediatric anaesthesia. The incidence may have decreased during the last decades, judging from several audits published recently. However, several reports of very long fasting intervals have also been published, in spite of the implementation of the 6-4-2 fasting regimens. In this review, we examine the physiological basis for various fasting recommendations, the temporal relationship between fluid intake and residual gastric content, and the pathophysiological effects of preoperative fasting, and review recent publications of various attempts to reduce the incidence of prolonged fasting in children. The pros and cons of the current guidelines will be addressed, and possible strategies for a future revision will be suggested.

A systematic review and meta-analysis comparing partial stomach partitioning gastrojejunostomy versus conventional gastrojejunostomy for malignant gastroduodenal obstruction.

PURPOSE: Partial stomach partitioning gastrojejunostomy (PSPGJ) was introduced as a palliative treatment for malignant gastric outlet obstruction (MGO) caused by unresectable gastric or periampullary cancers and suggested to offer advantages over conventional gastrojejunostomy (CGJ) in reducing the risk for delayed gastric emptying (DGE). However, insufficient evidence is available to allow a comprehensive view of the true value of PSPGJ. The present study aimed to show the advantages of PSPGJ in terms of alleviating DGE and improving postoperative recovery compared to CGJ. METHODS: A systematic literature search was performed, and studies comparing DGE and other perioperative and postoperative data including operation time, blood loss, total postoperative complications, anastomotic leak, postoperative period before oral intake, and/or hospital stay between PSPGJ and CGJ for MGO were incorporated. Risk ratio (RR) for binary variables and weighted mean difference (WMD) for continuous variables were calculated, and meta-analyses were performed. RESULTS: Seven studies containing 207 patients were included. The risk for DGE was significantly lower after PSPGJ (RR 0.32; 95%CI 0.17 to 0.60; P < 0.001). PSPGJ significantly reduced the postoperative hospital stay (WMD -6.1 days; 95%CI -8.9 to -3.3 days; P < 0.001). No significant differences were observed in the other variables between the groups. CONCLUSIONS: PSPGJ for MGO seems to offer significant advantages in terms of alleviating DGE and improving postoperative recovery compared to CGJ.

Perspectives on Using Fast-Dissolving Paracetamol for Mild-to-Moderate Pain Management in Elderly or Diabetic Patients with Delayed Gastric Emptying Rates: An Exploratory Study.

Purpose: Pain is considered a major clinical and socioeconomic problem worldwide. Delayed gastric emptying rates allegedly influence the suitability of pain-relief medications in patient populations such as the elderly and individuals with diabetes. Faster pain relief was reportedly achieved by using a fast-dissolving paracetamol (FD-APAP) formulation. This study aims to gain insights to healthcare professionals' (HCPs) perspectives towards using FD-APAP in addressing barriers of pain relief in patient populations susceptible to delayed gastric emptying rates. Patients and Methods: A two-step modified Delphi consensus study was conducted among a panel of 10 general practitioners (GPs) and four endocrinologists. The first step comprises in-depth discussions around evidence relevant to FD-APAP for pain management in patient populations with delayed gastric emptying rates (elderly/diabetics). The second step (a survey) was based on the summarized input from the first step. Consensus was accepted upon ≥70% agreement. Perspectives on pain management by FD-APAP for elderly patients were explored among GPs, while those for diabetic patients were explored among GPs and endocrinologists. Results: Consensus was achieved, whereby all panel members found FD-APAP to be favorable and relevant for pain management in the elderly and the diabetic patient populations. GPs additionally raised the consensus on the importance of considering comorbidities associated with diabetes while having minimal complications during pain management. Conclusion: The panel found the faster disintegration and absorption of FD-APAP relevant and useful for patients with delayed gastric emptying, wherein, pain in the elderly and those with diabetes could be treated effectively with limited side-effects.

Autonomic cardiogastric neural interaction after pulmonary vein isolation in patients with atrial fibrillation.

PURPOSE: Clinical significance of reduced vagal activity following pulmonary vein isolation (PVI) for atrial fibrillation (AF) remains unclear. Periesophageal vagal nerve injury following PVI may be a powerful contributing factor of decreased vagal tone. METHODS: Drug-refractory 51 AF patients (31 males, 64 ± 11 years), who underwent successful PVI, were enrolled. We performed esophagogastroduodenoscopy 2 days after PVI and assessed delayed gastric emptying (DGE). Additionally, the coefficient of variance of R-R interval (CVRR) as a surrogate for vagal tone was measured before PVI, as well as at 1 day and 3 months after PVI. The patients were divided into two groups, patients with DGE and patients without DGE, and changes in CVRR were compared. RESULTS: After PVI, 12 out of 51 patients (23.5%) had DGE. The baseline CVRR did not differ between the patients with (n = 12) and those without (n = 39) DGE (median 3.13%, interquartile range 1.69-5.13 vs. median 3.76%, interquartile range 2.96-5.90, P = 0.297). However, CVRR at 1 day after PVI was significantly lower in the patients with DGE than in those without (median 1.49%, interquartile range 0.90-2.19 vs. median 2.59%, interquartile range 1.58-3.86, P = 0.035), and then CVRR at 3 months became similar between the two groups, suggesting that the two groups had different changes in vagal tone after PVI. The recurrence of AF was similar at 3-6 months after PVI between the two groups. CONCLUSIONS: A significantly decreased CVRR immediately after PVI is a sign of DGE incidence, implying collateral damage to the esophagus.

Diagnostic Modalities Used in Diagnosing Gastroparesis: A Clinical Review.

Gastroparesis is associated with abnormal gastric motility characterized by delayed gastric emptying without any obvious mechanical gastric outlet obstruction or blockage. Gastroparesis is associated with significant morbidity and mortality. It is pertinent to make a timely diagnosis of gastroparesis so that prompt treatment can be initiated. The purpose of this clinical review article is to help the internist and the primary care providers to get a better idea of various diagnostic modalities used in diagnosing gastroparesis. We have also discussed the advantages and disadvantages of various diagnostic modalities based on the latest evidence.

Metoclopramide nasal spray for management of symptoms of acute and recurrent diabetic gastroparesis in adults.

Introduction: Gastroparesis (GP) is characterized by delayed gastric emptying in the absence of mechanical obstruction. About 75% of GP patients are females. Diabetes and idiopathic are the two commonest etiologies of GP. Up to two-thirds of the GP patients do not have significant symptom responses to medical therapies, and there is a paucity of available oral prokinetic agents with only one medication approved by the U.S. Food and Drug Administration (FDA) for this indication. The oral and parenteral formulations of metoclopramide were FDA approved in 1979 to treat symptoms of acute and recurrent diabetic GP. Now, more than 40 years later, a nasal preparation of metoclopramide (GimotiTM) was approved in June 2020 for the same indication.Areas covered: PubMed search using the keywords 'nasal metoclopramide' and 'diabetic gastroparesis.' This article aims to provide a concise review of the pharmacology, clinical efficacy, and tolerability of nasal metoclopramide.Expert opinion: The nasal formulation can be systemically absorbed without relying on the passage through a poorly emptying stomach, thus assuring the delivery of a therapeutic dose of metoclopramide, even during episodes of vomiting. Hence, metoclopramide nasal spray has the potential to be used during an acute flare, potentially avoiding hospitalizations.

Trying to stomach multiple myeloma: A case report.

We report a case of a 51-year-old male with minimal past medical history who presented to his primary care provider with nausea, vomiting and constipation in the outpatient setting. Concomitantly, he was found to have a renal injury, anemia and lytic lesions which were confirmed to be due to multiple myeloma. After further investigation of the gastrointestinal symptoms, he was diagnosed with gastroparesis. This case represents an unusual presentation of gastroparesis, diagnosed at the same time as multiple myeloma, for which there has yet to be a published association. Here we detail the case, review gastric emptying physiology, the diagnostic criteria for gastroparesis and hypothesize the connection if it might have with multiple myeloma.

Roux-en-Y versus single loop reconstruction in pancreaticoduodenectomy: A systematic review and meta-analysis.

BACKGROUND: Post-operative pancreatic fistula (POPF) and delayed gastric emptying (DGE) both remain problematic complications following pancreaticoduodenectomy. This systematic review and meta-analysis evaluates whether Roux-en-Y compared to a single loop reconstruction in pancreaticoduodenectomy significantly reduces rates of these complications. METHODS: A systematic review and meta-analysis was conducted according to the PRISMA guidelines by screening EMBASE, MEDLINE/PubMed, CENTRAL and bibliographic reference lists for comparative studies meeting the predetermined inclusion criteria. Post-operative outcome measures included: POPF, DGE, bile leak, operating time, blood loss, need for transfusion, wound infection, intra-abdominal collection, post-pancreatectomy haemorrhage, overall morbidity, re-operation, overall mortality, hospital length of stay. Pooled odds ratios or mean differences with 95% confidence intervals were calculated using either fixed- or random-effects models. RESULTS: Fourteen studies were identified including four randomised controlled trials (RCTs) and 10 observational studies reporting a total of 2,031 patients. Data synthesis showed no statistically significant difference between the two groups in any of the outcome measures except operating time, which was longer in those undergoing Roux-en-Y reconstruction. DISCUSSION: Roux-en-Y is not superior to single loop reconstruction in pancreaticoduodenectomy but may prolong operating time. Future high-quality randomised studies with appropriate study design and sample size power calculation may be required to further validate this conclusion.