Complication of Pancreatic Fistula and Bleeding After Pancreaticoduodenectomy in Treatment Periampullary Cancer

NCT04985071 | Completed

• 1 other identifier: VTrQuoc
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.

Conditions

Periampullary Cancer; Pancreatic Fistula; Bleeding

Keywords

Pancreatic Surgery

Outcome Measures

Primary Outcomes (1)

• Pancreatic fistula

  Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula

  90 post-operative days

Secondary Outcomes (1)

• Bleeding complication

  90 post-operative days

Interventions

Pancreaticoduodenectomy PROCEDURE

Patient with periampullary cancer will be underwent pancreaticoduodenectomy in 2 types of pancreatic-jejunal anastomosis reconstructions. We describe the postoperative complications (pancreatic fistula and bleeding) and analysis the risk factors relate to those complications

Also known as: Medical treatment after operation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with periampullary cancer will be underwent pancreaticoduodenectomy and will be followed-up after operation.

You may qualify if:

• Patients diagnosed with periampullary cancer meet the following criteria:
• Possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration.
• The postoperative pathology is adenocarcinoma (of the ampulla of Vater, common bile duct, duodenum or pancreas)

You may not qualify if:

• The patient has other organ's cancer beyond periampullary cancer.
• Patient's medical conditions contraindicate for anesthesia.
• The patient does not consent to participate in the study

Sponsors & Collaborators

• Vo Truong Quoc: lead

Study Sites (1)

Phan Minh Tri

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (1)

• Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.

  PMID: 32161987 RESULT

Related Links

• Guidelines for Perioperative Care for Pancreaticoduodenectomy

MeSH Terms

Conditions

Pancreatic Fistula; Hemorrhage

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• TruongQuoc Vo, Doctor

  University of Medicine and Pharmacy at HoChiMinh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Surgery Department, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 2, 2021
• Study Start: August 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)