Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled trial

被引:2
作者
Schrempf, Matthias C. [1 ]
Pinto, David R. M. [1 ]
Wolf, Sebastian [1 ]
Geissler, Bernd [1 ]
Sommer, Florian [1 ]
Hoffmann, Michael [1 ]
Vlasenko, Dmytro [1 ]
Gutschon, Johanna [1 ]
Anthuber, Matthias [1 ]
机构
[1] Univ Hosp Augsburg, Dept Gen Visceral & Transplantat Surg, Augsburg, Germany
关键词
Pylorus-preserving pancreaticoduodenectomy; Delayed gastric emptying; Pyloromyotomy; Randomised controlled trial; INTERNATIONAL STUDY-GROUP; QUALITY-OF-LIFE; GASTROENTERIC ANASTOMOSIS; PANCREATIC SURGERY; RETROCOLIC ROUTE; RECONSTRUCTION; PRESERVATION; METAANALYSIS; DEFINITION; MOTILITY;
D O I
10.1186/s13063-022-06032-2
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: Pylorus-preserving pancreaticoduodenectomy (ppPD) is a standard surgical procedure for the treatment of resectable neoplasms of the periampullary region. One of the most common postoperative complications after ppPD is delayed gastric emptying (DGE) which reduces quality of life, prevents a timely return to a solid oral diet and prolongs the length of hospital stay. In a retrospective analysis, intraoperative endoluminal pyloromyotomy was associated with a reduced rate of DGE. The aim of this study is to investigate the effect of intraoperative endoluminal pyloromyotomy on postoperative DGE after ppPD in a randomised and controlled setting. Methods: This randomised trial features parallel group design with a 1:1 allocation ratio and a superiority hypothesis. Patients with a minimum age of 18 years and an indication for ppPD are eligible to participate in this study and will be randomised intraoperatively to receive either endoluminal pyloromyotomy or atraumatic stretching of the pylorus. The sample size calculation (n=64 per study arm) is based on retrospective data. The primary endpoint is the rate of DGE within 30 days. Secondary endpoints are quality of life, operation time, estimated blood loss, length of hospital stay, morbidity and mortality. Discussion: DGE after ppPD is a common complication with an incomplete understood aetiology. Prevention of DGE could improve outcomes and enhance quality of life after one of the most common procedures in pancreatic surgery. This trial will expand the existing evidence on intraoperative pyloromyotomy, and the results will provide additional data on a simple surgical technique that could reduce the incidence of postoperative DGE.
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页数:8
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共 33 条
[21]   A prospective randomized comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying occurrence and long-term nutritional status [J].
Matsumoto, Ippei ;
Shinzeki, Makoto ;
Asari, Sadaki ;
Goto, Tadahiro ;
Shirakawa, Sachiyo ;
Ajiki, Tetsuo ;
Fukumoto, Takumi ;
Suzuki, Yasuyuki ;
Ku, Yonson .
JOURNAL OF SURGICAL ONCOLOGY, 2014, 109 (07) :690-696
[22]   Gastric phase 3 motility after pylorus-preserving pancreatoduodenectomy [J].
Ohtsuka, T ;
Takahata, S ;
Ohuchida, J ;
Takeda, T ;
Matsunaga, H ;
Yokohata, K ;
Yamaguchi, K ;
Chijiiwa, K ;
Tanaka, M .
ANNALS OF SURGERY, 2002, 235 (03) :417-423
[23]   Clinical validation and risk factors for delayed gastric emptying based on the International Study Group of Pancreatic Surgery (ISGPS) Classification [J].
Park, Joon Seong ;
Hwang, Ho Kyoung ;
Kim, Jae Keun ;
Cho, Sin Il ;
Yoon, Dong-Sup ;
Lee, Woo Jung ;
Chi, Hoon Sang .
SURGERY, 2009, 146 (05) :882-887
[24]   Factors associated with delayed gastric emptying after pancreaticoduodenectomy [J].
Parmar, Abhishek D. ;
Sheffield, Kristin M. ;
Vargas, Gabriela M. ;
Pitt, Henry A. ;
Kilbane, E. Molly ;
Hall, Bruce L. ;
Riall, Taylor S. .
HPB, 2013, 15 (10) :763-772
[25]   Effect of antecolic or retrocolic route of gastroenteric anastomosis on delayed gastric emptying after pancreaticoduodenectomy: A meta analysis of randomized controlled trials [J].
Qian, Dong ;
Lu, Zipeng ;
Jackson, Richard ;
Wu, Junli ;
Liu, Xinchun ;
Cai, Baobao ;
Wu, Pengfei ;
Yin, Jie ;
Xu, Qingcheng ;
Xu, Dong ;
Peng, Yunpeng ;
Jiang, Kuirong ;
Miao, Yi .
PANCREATOLOGY, 2016, 16 (01) :142-150
[26]   Intraoperative endoluminal pyloromyotomy as a novel approach to reduce delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy-a retrospective study [J].
Schrempf, Matthias C. ;
Pinto, David R. M. ;
Gutschon, Johanna ;
Schmid, Christoph ;
Hoffmann, Michael ;
Geissler, Bernd ;
Wolf, Sebastian ;
Sommer, Florian ;
Anthuber, Matthias .
LANGENBECKS ARCHIVES OF SURGERY, 2021, 406 (04) :1103-1110
[27]   Quality of life versus length of life considerations in cancer patients: A systematic literature review [J].
Shrestha, Anne ;
Martin, Charlene ;
Burton, Maria ;
Walters, Stephen ;
Collins, Karen ;
Wyld, Lynda .
PSYCHO-ONCOLOGY, 2019, 28 (07) :1367-1380
[28]   Endoscopic Therapies for Gastroparesis [J].
Su A. ;
Conklin J.L. ;
Sedarat A. .
Current Gastroenterology Reports, 2018, 20 (6)
[29]   Comparison of recovery of gastric phase III motility and gastric juice output after different types of gastrointestinal reconstruction following pylorus-preserving pancreatoduodenectomy [J].
Takahata, S ;
Ohtsuka, T ;
Nabae, T ;
Matsunaga, H ;
Yokohata, K ;
Yamaguchi, K ;
Chijiiwa, K ;
Tanaka, M .
JOURNAL OF GASTROENTEROLOGY, 2002, 37 (08) :596-603
[30]  
TRAVERSO LW, 1978, SURG GYNECOL OBSTET, V146, P959