Clinical trial · Interventional

Minimally Invasive Pancreatico-duodenectomy

Comparative Study Between Minimally Invasive Pancreatico-duodenectomy and Open Pancreatico-duodenectomy for Periampullary Tumors

NCT02807701CI-TRIAL-00050420LPDcompletedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreaticoduodenectomy	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Laparoscopic pancreaticoduodenectomy	Procedure	—	UNRESOLVED
Open pancreaticoduodenectomy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Laparoscopic pancreaticoduodenectomy
description
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
interventionNames
1. Procedure: Laparoscopic pancreaticoduodenectomy
type
ACTIVE_COMPARATOR
label
Open pancreaticoduodenectomy
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 65 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

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

References

Publications (6)

RESULTEl 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 23494109
RESULTEl 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 25759078
RESULTSenthilnathan 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 25789541
RESULTDokmak 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 25840531
RESULTCroome 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 25203880
RESULTGuerra 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.