Laparoscopic Versus Open Pancreatectomy

NCT00988793 | Withdrawn DMC

• 1 other identifier: 0908-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine whether laparoscopic distal pancreatectomy is associated with improved outcomes compared to open distal pancreatectomy.

  8 months to 5 years

Secondary Outcomes (1)

• To determine whether laparoscopic distal pancreatectomy is safe in patients with pancreatic adenocarcinoma

  8 months to 5 years

Study Arms (2)

Laparoscopic distal pancreatectomy

ACTIVE COMPARATOR

Comparison between two different types of surgery, open vs. laparoscopic distal pancreatectomy

Procedure: Laparoscopic distal pancreatectomy

Open distal pancreatectomy

ACTIVE COMPARATOR

Comparison between two different types of surgery, open vs. laparoscopic distal pancreatectomy

Procedure: Open distal pancreatectomy

Interventions

Laparoscopic distal pancreatectomy PROCEDURE

Comparison of two different types of surgery, laparoscopic versus distal pancreatectomy

Laparoscopic distal pancreatectomy

Open distal pancreatectomy PROCEDURE

Comparison of two different types of surgery, open versus laparoscopic distal pancreatectomy.

Open distal pancreatectomy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Christian M Schmidt, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

US (1)