Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT00988793
Status:
WITHDRAWN
Last Update Posted:
2021-06-21
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Open Pancreatectomy
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Randomized Trial of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Disease
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol needed major revisions; lack of money to institute changes
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will randomized patients to either open or laparoscopic pancreatic surgery. The primary purpose of the study is to determine whether laparoscopic distal pancreatectomy is associated with improved outcomes compared to open distal pancreatectomy.
Detailed Description:
Open distal pancreatectomy with or without splenectomy has been commonly employed for the treatment of a variety of pancreatic diseases. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed. Surgeons at Indiana University Hospital have safely applied laparoscopic surgery to very select patients with pancreatic disease since 2003. Recently, the outcomes of laparoscopic distal pancreatectomy at Indiana University in combination with multiple other institutions were reviewed and presented at the American Surgical Association Meeting 2008. These data suggest that laparoscopic when compared with open distal pancreatectomy may be associated with lower blood loss (357 vs. 588 cc, p\<0.01), fewer complications (40 vs. 57%, p\<0.01), and shorter hospital stays (5.9 vs. 9.0 days, p\<0.01). Furthermore, the laparoscopic approach was an independent predictor of shorter hospital stays. The main criticism of this retrospective study and similarly designed studies is that there is likely to be a selection bias in patients who undergo laparoscopic distal pancreatectomy which may account for the apparent positive results in favor of laparoscopic distal pancreatectomy. In other words, patient factors, not the operative approach may be more predictive of the outcome.
Based on these data, however, laparoscopic distal pancreatectomy appears to be at least as safe as open distal pancreatectomy. Currently, either technique is considered the "standard of care" at Indiana University Hospital as well as several other institutions in the US with expertise in laparoscopic pancreas surgery. To determine whether laparoscopic distal pancreatectomy is truly superior to open distal pancreatectomy in terms of outcomes, we have proposed to randomize patients to laparoscopic vs open distal pancreatectomy. In addition to the randomization, patients will be preoperatively stratified according to whether there is a diagnosis of pancreatic adenocarcinoma, so outcomes in this specific group of patients may be examined. Patients with adenocarcinoma will be randomized separately to insure equal groups in laparoscopic and open distal pancreatectomy groups for this specific diagnosis. Patients with neuroendocrine/islet cell tumors will also be randomized separately to insure equal groups in laparoscopic and open distal pancreatectomy groups for this specific diagnosis. Laparoscopic distal pancreatectomy for adenocarcinoma and neuroendocrine/islet cell tumors is uncommon (e.g., only 9 adenocarcinomas in last 5 years were performed laparoscopically at IU), thus it is clear from the outset that conclusions will be limited about patients with these diagnoses. Although this is being submitted as a single institution study, it will be strongly considered for multi-institutional study design in the near future. Patients will be enrolled on an intention-to-treat manner. Thus, patients who are randomized to laparoscopic distal pancreatectomy who require conversion to open pancreatectomy will still be included in the laparoscopic group in the overall comparative analyses. Subgroup analyses, however, will also be performed excluding this cross-over group.
Objectives:
Primary: The primary objective is to determine whether laparoscopic distal pancreatectomy is associated with improved outcomes compared to open distal pancreatectomy. Retrospective data suggests that blood loss, overall complication rate and hospital length of stay are positively influenced by the laparoscopic approach. Thus, these specific outcomes will be examined:
1. estimated blood loss
2. overall complication rate
3. hospital length of stay
Secondary:
1. to determine whether laparoscopic distal pancreatectomy is safe in patients with pancreatic adenocarcinoma
2. to establish a distal pancreatectomy registry
Based on these data, however, laparoscopic distal pancreatectomy appears to be at least as safe as open distal pancreatectomy. Currently, either technique is considered the "standard of care" at Indiana University Hospital as well as several other institutions in the US with expertise in laparoscopic pancreas surgery. To determine whether laparoscopic distal pancreatectomy is truly superior to open distal pancreatectomy in terms of outcomes, we have proposed to randomize patients to laparoscopic vs open distal pancreatectomy. In addition to the randomization, patients will be preoperatively stratified according to whether there is a diagnosis of pancreatic adenocarcinoma, so outcomes in this specific group of patients may be examined. Patients with adenocarcinoma will be randomized separately to insure equal groups in laparoscopic and open distal pancreatectomy groups for this specific diagnosis. Patients with neuroendocrine/islet cell tumors will also be randomized separately to insure equal groups in laparoscopic and open distal pancreatectomy groups for this specific diagnosis. Laparoscopic distal pancreatectomy for adenocarcinoma and neuroendocrine/islet cell tumors is uncommon (e.g., only 9 adenocarcinomas in last 5 years were performed laparoscopically at IU), thus it is clear from the outset that conclusions will be limited about patients with these diagnoses. Although this is being submitted as a single institution study, it will be strongly considered for multi-institutional study design in the near future. Patients will be enrolled on an intention-to-treat manner. Thus, patients who are randomized to laparoscopic distal pancreatectomy who require conversion to open pancreatectomy will still be included in the laparoscopic group in the overall comparative analyses. Subgroup analyses, however, will also be performed excluding this cross-over group.
Objectives:
Primary: The primary objective is to determine whether laparoscopic distal pancreatectomy is associated with improved outcomes compared to open distal pancreatectomy. Retrospective data suggests that blood loss, overall complication rate and hospital length of stay are positively influenced by the laparoscopic approach. Thus, these specific outcomes will be examined:
1. estimated blood loss
2. overall complication rate
3. hospital length of stay
Secondary:
1. to determine whether laparoscopic distal pancreatectomy is safe in patients with pancreatic adenocarcinoma
2. to establish a distal pancreatectomy registry
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: