Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD),Langenbeck's Archives of Surgery

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Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD)
Langenbeck's Archives of Surgery ( IF 2.1 ) Pub Date : 2022-07-04 , DOI: 10.1007/s00423-022-02583-9
J Busquets _{1,

2} , S Martín ₃ , Ll Secanella ₁ , M Sorribas ₁ , N Cornellà ₁ , J Altet ₄ , N Peláez ₁ , M Bajen ₅ , T Carnaval ₆ , S Videla _{6,

7} , J Fabregat _{1,

2}

Affiliation

Department of Hepatobiliary and Pancreatic Surgery, Bellvitge University Hospital, Research Group of Hepato-Biliary and Pancreatic Diseases, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, University of Barcelona, Carrer de la Feixa Llarga s/n, 08907, L´Hospitalet de Llobregat, Barcelona, Spain.
Departament de Ciències Clíniques, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB), c. Casanova, 143, 08036, Barcelona, Spain.
General and Digestive Surgery Service, Viladecans Hospital, Viladecans, Spain.
General and Digestive Surgery Service, Mar Hospital, Barcelona, Spain.
Department of Nuclear Medicine, Bellvitge University Hospital, University of Barcelona, Carrer de la Feixa Llarga s/n, 08907, L´Hospitalet de Llobregat, Barcelona, Spain.
Clinical Research Support Unit (HUB·IDIBELL), Clinical Pharmacology Department, Bellvitge University Hospital, Carrer de la Feixa Llarga s/n, 08907, L´Hospitalet de Llobregat, Barcelona, Spain.
Pharmacology Unit, Department of Pathology and Experimental Therapeutics, School of Medicine and Health Sciences, IDIBELL, University of Barcelona, Carrer de la Feixa Llarga s/n, 08907, L´Hospitalet de Llobregat, Barcelona, Spain.

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.

中文翻译：

经典 Whipple 或保留幽门的胰十二指肠切除术后胃排空延迟：一项随机临床试验 (QUANUPAD)

目的

多年来，保留幽门的胰十二指肠切除术（PPPD）一直是胰头病变切除的金标准。一些研究指出，与经典的 Whipple（即胰十二指肠切除术和胃窦切除术）相比，它涉及更多的延迟胃排空 (DGE)。我们的工作假设是经典 Whipple 的 DGE 发生率较低。我们旨在比较胰十二指肠切除术中 DGE 的发生率。

方法

这项务实的、随机的、开放标签的、单中心临床试验涉及接受经典 Whipple（研究组）或 PPPD（对照组）的患者。使用闪烁扫描法对胃排空进行临床评估。DGE 是根据国际胰腺外科研究组 (ISGPS) 标准定义的。次要终点是术后发病率、住院时间、人体测量和营养状况。

结果

共有 84 名患者被随机分配（每组 42 名）。研究组的 DGE 发生率为 50%（20/40，95% CI：35-65%），对照组为 62%（24/39，95% CI：46-75%） ( p = 0.260)。两组之间在术后发病率或住院时间方面没有观察到差异。术后 6 个月的人体测量：三头肌褶皱测量值为 12 毫米和 16 毫米（p = 0.021）。术后 5 周，三头肌褶皱测量值为 13 毫米和 16 毫米（p = 0.020），上臂周长分别为 26 厘米和 28 厘米（p = 0.030）。营养状况无显着差异。