Laparoscopic Versus Open Pancreatectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 28 June 2021
• Main ID: NCT00988793
• Date of registration: 01/10/2009
• Prospective Registration: No
• Primary sponsor: Indiana University
• Public title: Laparoscopic Versus Open Pancreatectomy
• Scientific title: Randomized Trial of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Disease
• Date of first enrolment: August 2009
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00988793
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Christian M Schmidt, MD
• Affiliation: Indiana University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pancreatectomy

Intervention(s)

Procedure: Open distal pancreatectomy

Procedure: Laparoscopic distal pancreatectomy

Primary Outcome(s)

The primary objective is to determine whether laparoscopic distal pancreatectomy is associated with improved outcomes compared to open distal pancreatectomy. [Time Frame: 8 months to 5 years]

Secondary Outcome(s)

To determine whether laparoscopic distal pancreatectomy is safe in patients with pancreatic adenocarcinoma [Time Frame: 8 months to 5 years]

Secondary ID(s)

0908-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors