NCT02807701

Brief Summary

Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary and pancreatic diseases including malignant and benign conditions. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care. Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited. In this prospective randomized study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD compared to conventional open PD.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 3, 2021

Status Verified

June 1, 2016

Enrollment Period

2.1 years

First QC Date

June 15, 2016

Last Update Submit

March 2, 2021

Conditions

Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • duration of hospital stay

    hospital stay

    one month

Secondary Outcomes (3)

  • postoperative pancreatic fistula

    30 days

  • operative time

    intraoperative hours

  • blood loss

    intraoperative hours

Study Arms (2)

Laparoscopic pancreaticoduodenectomy

ACTIVE COMPARATOR

Laparoscopic pancreaticoduodenectomy Under general anesthesia, the patient is placed in a supine position with the legs abducted. Carbon dioxide pneumoperitoneum is established using an open technique through a 10-mm trocar over the umbilicus. A 30 telescope is inserted to examine the peritoneal cavity, liver, stomach, and mesentric vessels.Then 4 to 6 more trocars are inserted under direct vision in the epigastrium and upper quadrants 1. dissection 2. reconstruction

Procedure: Laparoscopic pancreaticoduodenectomy

Open pancreaticoduodenectomy

ACTIVE COMPARATOR

Open pancreaticoduodenectomy Abdomen is opened from the Bilateral Subcostal incision. (Chevron's Incision) 2. Abdominal cavity is explored for metastasis especially in liver, base of mesentary, mesocolon and pelvis. Dissection Reconstruction Pancreaticogastrostomy Hepaticojejunostomy is next- Done in single layer and can be performed in interrupted or continuous fashion. Gastrojejunostomy is the final step of reconstruction.

Procedure: Open pancreaticoduodenectomy

Interventions

Laparoscopic pancreaticoduodenectomyPROCEDURE

Laparoscopic pancreaticoduodenectomy 1. dissection 2. reconstruction

Also known as: LPD
Laparoscopic pancreaticoduodenectomy
Open pancreaticoduodenectomyPROCEDURE

Open pancreaticoduodenectomy

Also known as: O PD
Open pancreaticoduodenectomy

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age from less than 70 years.
  • Tumor size less than or equal 3cm.
  • No vascular invasion.

You may not qualify if:

  • Multiple prior abdominal surgeries.
  • Body mass index \>40.
  • Locally advanced tumors .
  • Inability to withstand prolonged anesthesia.
  • Tumor size more than 3 cm.
  • Patients who received chemoradiotherapy.
  • Pregnant females.
  • Patients with cirrhotic liver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.

    PMID: 23494109RESULT

  • El Nakeeb A, Askr W, Mahdy Y, Elgawalby A, El Sorogy M, Abu Zeied M, Abdallah T, Abd Elwahab M. Delayed gastric emptying after pancreaticoduodenectomy. Risk factors, predictors of severity and outcome. A single center experience of 588 cases. J Gastrointest Surg. 2015 Jun;19(6):1093-100. doi: 10.1007/s11605-015-2795-2. Epub 2015 Mar 11.

    PMID: 25759078RESULT

  • Senthilnathan P, Srivatsan Gurumurthy S, Gul SI, Sabnis S, Natesan AV, Palanisamy NV, Praveen Raj P, Subbiah R, Ramakrishnan P, Palanivelu C. Long-term results of laparoscopic pancreaticoduodenectomy for pancreatic and periampullary cancer-experience of 130 cases from a tertiary-care center in South India. J Laparoendosc Adv Surg Tech A. 2015 Apr;25(4):295-300. doi: 10.1089/lap.2014.0502. Epub 2015 Mar 19.

    PMID: 25789541RESULT

  • Dokmak S, Fteriche FS, Aussilhou B, Bensafta Y, Levy P, Ruszniewski P, Belghiti J, Sauvanet A. Laparoscopic pancreaticoduodenectomy should not be routine for resection of periampullary tumors. J Am Coll Surg. 2015 May;220(5):831-8. doi: 10.1016/j.jamcollsurg.2014.12.052. Epub 2015 Jan 26.

    PMID: 25840531RESULT

  • Croome KP, Farnell MB, Que FG, Reid-Lombardo KM, Truty MJ, Nagorney DM, Kendrick ML. Total laparoscopic pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: oncologic advantages over open approaches? Ann Surg. 2014 Oct;260(4):633-8; discussion 638-40. doi: 10.1097/SLA.0000000000000937.

    PMID: 25203880RESULT

  • Guerra F, Levi Sandri GB, Amore Bonapasta S, Farsi M, Coratti A. The role of robotics in widening the range of application of minimally invasive surgery for pancreaticoduodenectomy. Pancreatology. 2016 Mar-Apr;16(2):293-4. doi: 10.1016/j.pan.2015.12.007. Epub 2015 Dec 23. No abstract available.

    PMID: 26774496RESULT

Related Links

Study Officials

  • Ayman El Nakeeb, MD

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterology surgical center, mansoura university

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 21, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 3, 2021

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share