Shark mouth pancreaticojejunostomy: a new enteric reconstruction procedure of pancreatic stump.
Journal
Chinese medical journal
ISSN: 2542-5641
Titre abrégé: Chin Med J (Engl)
Pays: China
ID NLM: 7513795
Informations de publication
Date de publication:
05 Jun 2019
05 Jun 2019
Historique:
pubmed:
22
3
2019
medline:
18
12
2019
entrez:
22
3
2019
Statut:
ppublish
Résumé
The enteric reconstruction procedure of pancreatic stump after pancreaticoduodenectomy remains to be the critical factor influencing the mortality and morbidity. No widely accepted surgical procedure for the pancreaticojejunostomy has been erected yet. We have developed a new technique of pancreaticojejunostomy named "shark mouth pancreaticojejunostomy." The aim of this study is to assess the efficacy of "shark mouth pancreaticojejunostomy." This is a prospective single-arm observational study to evaluate the clinical efficacy of "shark mouth pancreaticojejunostomy." Patients with diseases, in whom a pancreaticoduodenectomy is indicated, would be recruited from Peking University Third Hospital. The hypothesis to be tested is that a "shark mouth pancreaticojejunostomy" will reduce fistula rate from around 20% to less than 10%. A sample size of 120 patients will be needed. The primary endpoint is the incidence rate of postoperative pancreatic fistula (POPF). The secondary endpoints of the study are anastomosis time, postoperative hospital stay, and morbidities besides the POPF such as the hemorrhage. Enrolled patients will undergo pancreaticoduodenectomy and be followed up for 3 months. The relevant data will be monitored and recorded. The current trial will explore the therapeutic value of the newly raised pancreaticojejunostomy procedure as the "shark mouth pancreaticojejunostomy." Its theoretical base and pragmatic feature will promise high external validity. Clinical Trials.gov: NCT03366038; https://www.clinicaltrials.gov.
Sections du résumé
BACKGROUND
BACKGROUND
The enteric reconstruction procedure of pancreatic stump after pancreaticoduodenectomy remains to be the critical factor influencing the mortality and morbidity. No widely accepted surgical procedure for the pancreaticojejunostomy has been erected yet. We have developed a new technique of pancreaticojejunostomy named "shark mouth pancreaticojejunostomy." The aim of this study is to assess the efficacy of "shark mouth pancreaticojejunostomy."
METHODS
METHODS
This is a prospective single-arm observational study to evaluate the clinical efficacy of "shark mouth pancreaticojejunostomy." Patients with diseases, in whom a pancreaticoduodenectomy is indicated, would be recruited from Peking University Third Hospital. The hypothesis to be tested is that a "shark mouth pancreaticojejunostomy" will reduce fistula rate from around 20% to less than 10%. A sample size of 120 patients will be needed. The primary endpoint is the incidence rate of postoperative pancreatic fistula (POPF). The secondary endpoints of the study are anastomosis time, postoperative hospital stay, and morbidities besides the POPF such as the hemorrhage. Enrolled patients will undergo pancreaticoduodenectomy and be followed up for 3 months. The relevant data will be monitored and recorded.
CONCLUSIONS
CONCLUSIONS
The current trial will explore the therapeutic value of the newly raised pancreaticojejunostomy procedure as the "shark mouth pancreaticojejunostomy." Its theoretical base and pragmatic feature will promise high external validity.
TRIAL REGISTRATION
BACKGROUND
Clinical Trials.gov: NCT03366038; https://www.clinicaltrials.gov.
Identifiants
pubmed: 30896569
doi: 10.1097/CM9.0000000000000219
pmc: PMC6629351
doi:
Banques de données
ClinicalTrials.gov
['NCT03366038']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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