To determine whether time to functional recovery is shorter after LDP than after ODP for symptomatic benign, premalignant and malignant disease of the distal pancreas in an enhanced recovery setting.
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Health condition
pancreasaandoeningen/pancreastumoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the time (days) to functional recovery, defined as all of
the following: independently mobile at the preoperative level, sufficient pain
control with oral medication only, ability to maintain sufficient (> 50%) daily
required caloric intake, no intravenous fluid administration and no signs of
infection.
Secondary outcome
Main secondary outcome is the occurrence of major complications (i.e.
Clavien-Dindo score of III or higher). Other secondary outcomes are
I)intraoperative parameters such as splenectomy, conversion, operating time,
blood loss and transfusion, II)postoperative outcomes such as complications,
intensive care admission, length of hospital stay and readmission and
III)pathology outcomes such as resection margin status and number of lymph
nodes resected.
Background summary
Observational cohort studies suggest that laparoscopic distal pancreatectomy
(LDP) as compared to open distal pancreatectomy (ODP) is associated with better
outcomes, such as less intraoperative blood loss and reduced morbidity and
length of hospital stay, without increased costs. However, selection bias has
substantially influenced these findings and case-matched studies failed to
demonstrate superiority of LDP. A randomized trial is therefore needed.
Study objective
To determine whether time to functional recovery is shorter after LDP than
after ODP for symptomatic benign, premalignant and malignant disease of the
distal pancreas in an enhanced recovery setting.
Study design
A randomized controlled, parallel-group, pragmatic, blinded, superiority
multicenter trial in 17 centers of the Dutch Pancreatic Cancer Group. The study
protocol is designed according to the SPIRIT 2013 guidelines.
Intervention
Intervention: Laparoscopic distal pancreatectomy (+ / - splenectomy).
Control: Open distal pancreatectomy (+ / - splenectomy).
Study burden and risks
Recent meta-analyses of cohort studies suggest that LDP is superior to ODP
concerning blood loss, complications and hospital stay but these benefits could
not be confirmed by case-matched studies. Subjects will not undergo additional
investigations and interventions due to participation in the LEOPARD study and
therefore risks to subjects involved in this trial are similar to every other
patient undergoing distal pancreatectomy in routine clinical practice.
Potential benefits for subjects in the investigational treatment arm could be
less intraoperative blood loss, fewer major complications, expedited functional
recovery, a shorter hospital stay and better cosmesis.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Age equal or above 18 years;
* Indication for elective distal pancreatectomy (+ / - splenectomy) because of proven or suspected symptomatic benign, premalignant or malignant disease of the distal pancreas (as defined in section 4.4);
* Tumor meeting the Yonsei criteria33:
* Fit to undergo distal pancreatectomy according to the surgeon and anaesthetist.
Exclusion criteria
* Tumor or cyst larger than 8 cm;
* Distal pancreatectomy is not the sole procedure, so when a surgical intervention (resection / ablation) of other organs besides the distal pancreas or spleen is performed (minor procedures, such as cholecystectomy, are allowed);
* Chronic pancreatitis (according to the M-ANNHEIM criteria, see Appendix 2 for detailed definition);
* Previous radiotherapy for pancreatic cancer;
* Pregnancy;
* Participation in another study with interference of study outcomes.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52031.018.15 |
| OMON | NL-OMON26260 |