Clinical trial NCT05017207: Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy
Official title: Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Fistula
Keywords: Risk factor
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Periampullary cancer with postoperative pathology is adenocarcinoma

Brief summary: Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors

Detailed description: This study will conduct at two centers at the same time: University of Medicine and Pharmacy Center and Cho Ray Hospital. The patients will be consulted to participate to this research from September, 2021 to April, 2023.

Plan for conducting study:

* The investigator consults and gets consensus form of the patient with periampullary cancer.
* The patient will be prepared for pancreaticoduodenectomy: pre-operative laboratory test, pre-operative biliary drainage, anesthetic checking.
* The investigator collected intr-operative data, include type of pancreatic-duodenal reconstruction, type of pancreatic duct's drainage, quantity of blood loss and blood transfusion.
* The investor follows post-operative period.
* If there are pancreatic fistula appear, the investigator will collect the clinical signs, laboratory test changing, re-operative morphology.
* The investigator analysis the risk factors of pancreatic fistula.

Data analysis:

* To determine the incidence of pancreatic fistula, the morphology of pancreatic fistula, descriptive statistics will be used.
* To determine the risk factors of pancreatic fistula, logistic regression will be used.

Sample size:

* The investigator plans to collect 145 patients in the research period.

Plan for missing data:

* Any case that miss information will be removed from the study.

Eligibility criteria: Inclusion Criteria:

* Patient with periampullary cancer and can be performed pancreaticoduodenectomy.
* Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.

Exclusion Criteria:

* The patient does not consent to participate in the study

Primary outcomes:
measure: Pancreatic fistula
timeFrame: 30 days of post-operative period
measure: Risk factors relate to pancreatic fistula
timeFrame: 30 days of post-operative period
Secondary outcomes:
measure: Short-term result in treatment of post-operative pancreatic fistula
timeFrame: 30 days of post-operatvive period
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center of HCMC
Study officials:
affiliation: University of Medicine and Pharmacy at HoChiMinh City
name: Truong Quoc Vo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawaida H, Kono H, Hosomura N, Amemiya H, Itakura J, Fujii H, Ichikawa D. Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery. World J Gastroenterol. 2019 Jul 28;25(28):3722-3737. doi: 10.3748/wjg.v25.i28.3722.