Dataset Information

Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD).

ABSTRACT:

Purpose

Pylorus-preserving pancreatoduodenectomy (PPPD) has been the gold standard for pancreatic head lesion resection for several years. Some studies have noted that it involves more delayed gastric emptying (DGE) than classical Whipple (i.e., pancreatoduodenectomy with antrectomy). Our working hypothesis was that the classical Whipple has a lower incidence of DGE. We aimed to compare the incidence of DGE among pancreatoduodenectomy techniques.

Methods

This pragmatic, randomized, open-label, single-center clinical trial involved patients who underwent classical Whipple (study group) or PPPD (control group). Gastric emptying was clinically evaluated using scintigraphy. DGE was defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria. The secondary endpoints were postoperative morbidity, length of hospital stay, anthropometric measurements, and nutritional status.

Results

A total of 84 patients were randomized (42 per group). DGE incidence was 50% (20/40, 95% confidence interval (95% CI): 35-65%) in the study group and 62% (24/39, 95% CI: 46-75%) in the control group (p = 0.260). No differences were observed between both groups regarding postoperative morbidity or length of hospital stay. Anthropometric measurements at 6 months post-surgery: triceps fold measurements were 12 mm and 16 mm (p = 0.021). At 5 weeks post-surgery, triceps fold measurements were 13 mm and 16 mm (p = 0.020) and upper arm circumferences were 26 cm and 28 cm (p = 0.030). No significant differences were observed in nutritional status.

Conclusion

DGE incidence and severity did not differ between classical Whipple and PPPD. Some anthropometric measurements may indicate a better recovery with PPPD.

Trial registration

ClinicalTrials.gov Identifier: NCT03984734.

SUBMITTER: Busquets J

PROVIDER: S-EPMC9468034 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD).

Busquets J J Martín S S Secanella Ll L Sorribas M M Cornellà N N Altet J J Peláez N N Bajen M M Carnaval T T Videla S S Fabregat J J

Langenbeck's archives of surgery 20220704 6

<h4>Purpose</h4>Pylorus-preserving pancreatoduodenectomy (PPPD) has been the gold standard for pancreatic head lesion resection for several years. Some studies have noted that it involves more delayed gastric emptying (DGE) than classical Whipple (i.e., pancreatoduodenectomy with antrectomy). Our working hypothesis was that the classical Whipple has a lower incidence of DGE. We aimed to compare the incidence of DGE among pancreatoduodenectomy techniques.<h4>Methods</h4>This pragmatic, randomized ...[more]

PMID: 35786739

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Project description:BackgroundDelayed gastric emptying is a serious complication of pancreaticoduodenectomy. The effect of pylorus removal on delayed gastric emptying has not been well evaluated.Study designWe searched five databases (PubMed, EMBASE and the Cochrane Central Register of Controlled Trials, Scopus and Web of Science) up to July 2014. The meta-regression analysis was performed to evaluate any factors accountable for the heterogeneity. Publication bias was assessed by Egger's test, and corrected by Duval's trim and fill method. Subgroup analyses were conducted for different surgical techniques of pyloric removal. Other intraoperative and postoperative parameters were compared between two groups.ResultsWe included 27 studies involving 2,599 patients, with a moderate-high heterogeneity for primary outcome (I(2) = 63%). Meta-regression analysis showed that four variables primarily contributed to the heterogeneity, namely nasogastric tube intubation time, solid food start time, preoperative diabetes percentage and the number of patients in pylorus-preserving group. After excluding four studies, the remaining twenty-three studies showed reduced heterogeneity (I(2) = 51%). Then we used Duval's trim and fill method to correct publication bias. The corrected MH odds ratio was 0.78 (95% CI: 0.52-1.17). A subgroup analysis showed that pylorus removal tends to reduce delayed gastric emptying incidence for subtotal stomach-preserving pancreaticoduodenectomy or pylorus-resecting pancreaticoduodenectomy, compared with pylorus-preserving group. However, standard Whipple procedure failed to show any significant reduction of DGE compared with pylorus-removal group. No significant differences were observed in terms of length of hospital stay, infection and pancreatic fistula; however, pylorus removal resulted in longer operation time, more blood loss and higher mortality.ConclusionThe pylorus removal does not significantly reduce the overall incidence of delayed gastric emptying. Subtotal stomach-preserving pancreaticoduodenectomy or pylorus-resecting pancreaticoduodenectomy tends to reduce delayed gastric emptying incidence, but needs further validation.

Project description:IntroductionDelayed gastric emptying (DGE) is frequent after pancreaticoduodenectomy (PD). Although often associated with postoperative pancreatic fistula, the precise pathogenesis in patients with no underlying complications remains unclear. There is evidence to suggest that, after surgery, aberrant electrical pathways are formed in the stomach which could contribute to the development of DGE.Gastric Alimetry is a novel technology which measures the electrical activity of the stomach non-invasively using an array of electrodes applied to the skin of the abdomen. This technique, termed body surface gastric mapping (BSGM), has been validated in normal controls and in patients with functional dyspepsia syndromes. This study will investigate the efficacy and feasibility of using BSGM to assess gastric motility in patients who undergo PD.Methods and analysisThis prospective cohort study will be conducted at a single large volume hepatobiliary unit in the UK. 50 patients who are planned to undergo PD will be included. BSGM measurement will be performed at four timepoints viz: preoperatively, day 4 postoperatively, at discharge and 6 months postoperatively. Key parameters of BSGM measurement, including wave amplitude, frequency and directional vector, will be measured at each timepoint and compared between different patient subgroups. Symptoms will be self-reported by patients during the recording using an iPad application designed for this purpose. Quality of life and patient experience will be assessed using standardised questionnaires at the end of the follow-up period.Ethics and disseminationThe protocol has been approved by the research ethics committees of Newcastle University and the Health Research Authority (HRA) of the UK (ethical approval IRAS ID 305302). Findings will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberThis study will automatically be registered with the ISRCTN registry by the HRA as part of the ethics approval process.

Dataset Information

Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD).

Purpose

Methods

Results

Conclusion

Trial registration

Publications

Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD).

Similar Datasets

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