Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141044
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-08-09
Brief Title:
Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
PANDREAS Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy a Multicentre Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANDREAS
Brief Summary:
Postoperative pancreatic fistula POPF is a major source of morbidity and mortality after pancreatic resection especially after distal pancreatectomy PD Today POPF remains one of the main causes of hospital length of stay and healthcare costs Numerous surgical techniques have been tested to reduce its incidence without success so the current standard for the management of POPF and the avoidance of associated complications is intraoperative drain placement However surgically placed drains are not without risk In recent years many studies mostly retrospective have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity These studies suggest that patients may benefit from not having a drain placed This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy
Detailed Description:
A prospective randomised multicentre multicentre randomised non-inferiority study is designed The aim is to study whether patients who undergo distal pancreatectomy can benefit from the non-placement of a drain in terms of clinically relevant postoperative pancreatic fistula and Clavien-Dindo morbidity greater than or equal to 3
Information will be collected for all patients undergoing distal pancreatectomy surgery at the collaborating centres who upon invitation voluntarily agree to participate in the study Those who have agreed to participate given written consent and meet the inclusion criteria and none of the exclusion criteria will be randomly assigned to one of the following treatment groups
Control group patients who after distal pancreatectomy in whom abdominal drainage is placed
Intervention group patients who after distal pancreatectomy will be omitted the placement of an abdominal drain
Following the postoperative pancreatic fistula score according to the DISPAIR criteria patients included in the present study will be stratified according to the preoperative risk of postoperative pancreatic fistula into extreme high moderate and low
The standards of surgical technique to be followed in both open and minimally invasive distal pancreatectomy were agreed by consensus
Each patient will be followed up for 6 months from the time of randomisation day of surgeryThose responsible for the recruitment and selection of patients for inclusion in the research project belong to the Multidisciplinary Committee of Hepatobiliary and Pancreatic Surgery of each centre Surgical intervention postoperative management and perioperative morbidity will be evaluated by the surgeon responsible for the patient A patient recruitment period of 2 years is estimated After a follow-up period of 6 months an analysis of postoperative pancreatic fistula rate perioperative morbidity biochemical parameters and quality of life will be performed
Information will be collected for all patients undergoing distal pancreatectomy surgery at the collaborating centres who upon invitation voluntarily agree to participate in the study Those who have agreed to participate given written consent and meet the inclusion criteria and none of the exclusion criteria will be randomly assigned to one of the following treatment groups
Control group patients who after distal pancreatectomy in whom abdominal drainage is placed
Intervention group patients who after distal pancreatectomy will be omitted the placement of an abdominal drain
Following the postoperative pancreatic fistula score according to the DISPAIR criteria patients included in the present study will be stratified according to the preoperative risk of postoperative pancreatic fistula into extreme high moderate and low
The standards of surgical technique to be followed in both open and minimally invasive distal pancreatectomy were agreed by consensus
Each patient will be followed up for 6 months from the time of randomisation day of surgeryThose responsible for the recruitment and selection of patients for inclusion in the research project belong to the Multidisciplinary Committee of Hepatobiliary and Pancreatic Surgery of each centre Surgical intervention postoperative management and perioperative morbidity will be evaluated by the surgeon responsible for the patient A patient recruitment period of 2 years is estimated After a follow-up period of 6 months an analysis of postoperative pancreatic fistula rate perioperative morbidity biochemical parameters and quality of life will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None