Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study

Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreas Neoplasm
• Intervention / Treatment: Procedure: laparoscopic assisted pancreaticoduodenectomy; Procedure: Open pancreaticduodenctomy

Detailed Description

Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers [4,5]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy[6]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy[7,8]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed aly ahmed, Assist.lecturer; Phone Number: 01067575588; Email: mohamed1234ali1991@gmail.com
• Study Contact Backup: Name: Mostafa Mahmoud Mohammed Sayed, Assist.prof; Phone Number: +201271207839; Email: mostafa.sayed@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age less than 70 years.
2. resectable tumour,
3. fit for surgery

Exclusion Criteria:

1. patients with jaundice with serum bilirubin above 200mml/dl.
2. patients with bleeding tendency until corrected.
3. patients with advanced and metastatic malignancy.
4. patients with cardiopulmonary diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laparoscopic assisted pancreaticoduodenctomy; If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.	Procedure: laparoscopic assisted pancreaticoduodenectomy; laparoscopic assisted pancreaticoduodenectomy.
ACTIVE_COMPARATOR: Open pancreaticduodenctomy; criteria are met ,these group of patients will undergo open pancreaticoduodenctomy	Procedure: Open pancreaticduodenctomy; Open pancreaticduodenctomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain.	Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy	Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation
Blood loss	Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy	Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation
Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).	Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy	Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative haemorrhage	Compare between the postoperative haemorrhage by cc in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 2 weeks
Postoperative wound infection.	Compare between the postoperative wound infection in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 2 weeks
Starting oral feeding	Compare between starting oral feeding in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 3 days after operation
Postoperative 30 days mortality rate.	Compare between the Postoperative 30 days mortality rate in the open and laparoscopic assisted pancreaticoduodenectomy	In the first 30days after operation

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Newhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24.
• Erratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. No abstract available.
• Correction to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. No abstract available.
• Bausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (ACTUAL): July 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: Pancreaticoduodenectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No