Status:
WITHDRAWN
Laparoscopic Versus Open Pancreatectomy
Lead Sponsor:
Indiana University
Conditions:
Pancreatectomy
Eligibility:
All Genders
18-89 years
Phase:
NA
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 imp...
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 increasingl...
Eligibility Criteria
Inclusion
- All patients who are eligible for open distal pancreatectomy are also eligible for laparoscopic distal pancreatectomy. There are no absolute contraindications. The only situations where a patient is ineligible is if he/she prefers one approach over the other or the individual surgeon prefers one approach over the other.
- NOTE: Patients in whom there is a suspicion of a high likelihood of metastatic pancreatic cancer (minority of patients on trial) will undergo a diagnostic laparoscopy. If the tumor is metastatic (not confined to the pancreas) then the patient is no longer a candidate for any distal pancreatectomy (or the trial). The procedure of diagnostic laparoscopy in this setting is a potential confounder of a trial that randomizes patients to laparoscopic versus open distal pancreatectomy. Due to the importance of cancer patients to this trial, instead of excluding patients from randomization simply because they are undergoing laparoscopy, we have set some limits on the diagnostic laparoscopy. The limits include the use of 2 laparoscopic ports (total) and the diagnostic laparoscopy must be performed at the same setting as the distal pancreatectomy. Thus, after randomization to open distal pancreatectomy, if a patient goes to the operating room, the patient may undergo diagnostic laparoscopy with these limits (2 ports, same setting surgery) prior to undergoing open distal pancreatectomy. This is not an issue with a patient who is randomized for laparoscopic distal pancreatectomy, since when the patient goes to the operating room for diagnostic laparoscopy, they may be transitioned into laparoscopic distal pancreatectomy which allows 5 ports total.
- Patients will be eligible for enrollment in the study if they have a pancreas disease or condition for which they are to undergo distal pancreatectomy. Indications for distal pancreatectomy will be determined by the surgeon caring for the patient.
- Patients must undergo informed consent for the study prior to surgery.
- Patients must be eligible to undergo both open or laparoscopic distal pancreatectomy at all times up until randomization occurs.
- Female patients of child-bearing age must have a negative urine or serum pregnancy test prior to enrollment.
- Patients randomized to laparoscopic technique who require conversion to open technique will remain on trial due to the intention-to-treat design of the study.
Exclusion
- Patients who despite pancreas disease or condition are not fit surgical candidates and thus will not undergo distal pancreatectomy.
- Patients who fail to be eligible to undergo both open or laparoscopic distal pancreatectomy at anytime up until randomization occurs.
- Patients undergoing total pancreatectomy.
- Patients undergoing distal pancreatectomy who have had previous right-sided pancreatic resection (i.e., pancreaticoduodenectomy)
- Failure to sign informed consent.
- Pediatric patients (\<18 years of age) are excluded from this study.
- Patients who are pregnant.
- Patients with extensive pancreatitis or peri-pancreatic inflammation have a relative contraindication.
- Patients with portal or sinistral hypertension have a relative contraindication.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00988793
End Date
October 1 2021
Last Update
June 21 2021
Active Locations (1)
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1
Indiana University Hospital
Indianapolis, Indiana, United States, 46202